[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803]
[Page 38-55]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 803--MEDICAL DEVICE REPORTING
Subpart A--General Provisions
Sec.
803.1 Scope.
803.3 Definitions.
803.9 Public availability of reports.
803.10 General description of reports required from user facilities,
importers, and manufacturers.
803.11 Obtaining the forms.
803.12 Where to submit reports.
803.13 English reporting requirement.
803.14 Electronic reporting.
803.15 Requests for additional information.
803.16 Disclaimers.
803.17 Written MDR procedures.
803.18 Files and distributor records.
803.19 Exemptions, variances, and alternative reporting requirements.
Subpart B--Generally Applicable Requirements for Individual Adverse
Event Reports
803.20 How to report.
803.21 Reporting codes.
803.22 When not to file.
Subpart C--User Facility Reporting Requirements
803.30 Individual adverse event reports; user facilities.
803.32 Individual adverse event report data elements.
803.33 Annual reports.
Subpart D-- Importer Reporting Requirement
803.40 Individual adverse event reporting requirements; importers.
803.42 Individual adverse event report data elements.
Subpart E--Manufacturer Reporting Requirements
803.50 Individual adverse event reports; manufacturers.
803.52 Individual adverse event report data elements.
803.53 Five-day reports.
803.55 Baseline reports.
803.56 Supplemental reports.
803.58 Foreign manufacturers.
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Source: 60 FR 63597, Dec. 11, 1995, unless otherwise noted.
[[Page 39]]
Subpart A--General Provisions
Sec. 803.1 Scope.
(a) This part establishes requirements for medical device reporting.
Under this part, device user facilities, importers, and manufacturers,
as defined in Sec. 803.3, must report deaths and serious injuries to
which a device has or may have caused or contributed, must establish and
maintain adverse event files, and must submit to FDA specified followup
and summary reports. Medical device distributors, as defined in
Sec. 803.3, are also required to maintain records of incidents (files).
Furthermore, manufacturers and importers are also required to report
certain device malfunctions. These reports will assist FDA in protecting
the public health by helping to ensure that devices are not adulterated
or misbranded and are safe and effective for their intended use.
(b) This part supplements and does not supersede other provisions of
this subchapter, including the provisions of part 820 of this chapter.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
[60 FR 63597, Dec. 11, 1995, as amended at 62 FR 13306, Mar. 20, 1997;
65 FR 4118, Jan. 26, 2000]
Sec. 803.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Ambulatory surgical facility (ASF) means a distinct entity that
operates for the primary purpose of furnishing same day outpatient
surgical services to patients. An ASF may be either an independent
entity (i.e., not a part of a provider of services or any other
facility) or operated by another medical entity (e.g., under the common
ownership, licensure or control of an entity). An ASF is subject to this
regulation regardless of whether it is licensed by a Federal, State,
municipal, or local government or regardless of whether it is accredited
by a recognized accreditation organization. If an adverse event meets
the criteria for reporting, the ASF must report that event regardless of
the nature or location of the medical service provided by the ASF.
(c) Become aware means that an employee of the entity required to
report has acquired information reasonably suggesting a reportable
adverse event has occurred.
(1) Device user facilities are considered to have ``become aware''
when medical personnel, as defined in paragraph (s) of this section, who
are employed by or otherwise formally affiliated with the facility,
acquire such information about a reportable event.
(2) Manufacturers are considered to have become aware of an event
when:
(i) Any employee becomes aware of a reportable event that is
required to be reported within 30 days or that is required to be
reported within 5 days under a written request from FDA under
Sec. 803.53(b); and
(ii) Any employee, who is a person with management or supervisory
responsibilities over persons with regulatory, scientific, or technical
responsibilities, or a person whose duties relate to the collection and
reporting of adverse events, becomes aware that a reportable MDR event
or events, from any information, including any trend analysis,
necessitate remedial action to prevent an unreasonable risk of
substantial harm to the public health.
(3) Importers are considered to have become aware of an event when
any employee becomes aware of a reportable event that is required to be
reported by an importer within 30 days.
(d) Caused or contributed means that a death or serious injury was
or may have been attributed to a medical device, or that a medical
device was or may have been a factor in a death or serious injury,
including events occurring as a result of:
(1) Failure;
(2) Malfunction;
(3) Improper or inadequate design;
(4) Manufacture;
(5) Labeling; or
(6) User error.
(e)(1) Device family means a group of one or more devices
manufactured by or for the same manufacturer and having the same:
(i) Basic design and performance characteristics related to device
safety and effectiveness,
(ii) Intended use and function, and
[[Page 40]]
(iii) Device classification and product code.
(2) Devices that differ only in minor ways not related to safety or
effectiveness can be considered to be in the same device family. Factors
such as brand name and common name of the device and whether the devices
were introduced into commercial distribution under the same 510(k) or
premarket approval application (PMA), may be considered in grouping
products into device families.
(f) Device user facility means a hospital, ambulatory surgical
facility, nursing home, outpatient diagnostic facility, or outpatient
treatment facility as defined in paragraphs (b), (l), (t), (u), and (v),
respectively, of this section, which is not a ``physician's office,'' as
defined in paragraph (x) of this section. School nurse offices and
employee health units are not device user facilities.
(g) Distributor means, for the purposes of this part, any person
(other than the manufacturer or importer) who furthers the marketing of
a device from the original place of manufacture to the person who makes
final delivery or sale to the ultimate user, but who does not repackage
or otherwise change the container, wrapper or labeling of the device or
device package. One who repackages or otherwise changes the container,
wrapper, or labeling, is a manufacturer under paragraph (o) of this
section.
(h) [Reserved]
(i) Expected life of a device (required on the manufacturer's
baseline report) means the time that a device is expected to remain
functional after it is placed into use. Certain implanted devices have
specified ``end of life'' (EOL) dates. Other devices are not labeled as
to their respective EOL, but are expected to remain operational through
maintenance, repair, upgrades, etc., for an estimated period of time.
(j) FDA means the Food and Drug Administration.
(k) Five-day report means a medical device report that must be
submitted by a manufacturer to FDA pursuant to Sec. 803.53, on FDA Form
3500A or electronic equivalent as approved under Sec. 803.14, within 5
work days.
(l) Hospital means a distinct entity that operates for the primary
purpose of providing diagnostic, therapeutic (medical, occupational,
speech, physical, etc.), surgical and other patient services for
specific and general medical conditions. Hospitals include general,
chronic disease, rehabilitative, psychiatric, and other special-purpose
facilities. A hospital may be either independent (e.g., not a part of a
provider of services or any other facility) or may be operated by
another medical entity (e.g., under the common ownership, licensure or
control of another entity). A hospital is covered by this regulation
regardless of whether it is licensed by a Federal, State, municipal or
local government or whether it is accredited by a recognized
accreditation organization. If an adverse event meets the criteria for
reporting, the hospital must report that event regardless of the nature
or location of the medical service provided by the hospital.
(m) Importer means, for the purposes of this part, any person who
imports a device into the United States and who furthers the marketing
of a device from the original place of manufacture to the person who
makes final delivery or sale to the ultimate user, but who does not
repackage or otherwise change the container, wrapper, or labeling of the
device or device package. One who repackages or otherwise changes the
container, wrapper, or labeling, is a manufacturer under paragraph (o)
of this section.
(n) Malfunction means the failure of a device to meet its
performance specifications or otherwise perform as intended. Performance
specifications include all claims made in the labeling for the device.
The intended performance of a device refers to the intended use for
which the device is labeled or marketed, as defined in Sec. 801.4 of
this chapter.
(o) Manufacturer means any person who manufactures, prepares,
propagates, compounds, assembles, or processes a device by chemical,
physical, biological, or other procedure. The term includes any person
who:
(1) Repackages or otherwise changes the container, wrapper or
labeling of a
[[Page 41]]
device in furtherance of the distribution of the device from the
original place of manufacture;
(2) Initiates specifications for devices that are manufactured by a
second party for subsequent distribution by the person initiating the
specifications;
(3) Manufactures components or accessories which are devices that
are ready to be used and are intended to be commercially distributed and
intended to be used as is, or are processed by a licensed practitioner
or other qualified person to meet the needs of a particular patient; or
(4) Is the U.S. agent of a foreign manufacturer.
(p) Manufacturer or importer report number means the number that
uniquely identifies each individual adverse event report submitted by a
manufacturer or importer. This number consists of three parts as
follows:
(1) The FDA registration number for the manufacturing site of the
reported device, or the registration number for the importer. (If the
manufacturing site or the importer does not have a registration number,
FDA will assign a temporary MDR reporting number until the site is
officially registered. The manufacturer or importer will be informed of
the temporary number.);
(2) The four-digit calendar year in which the report is submitted;
and
(3) The five-digit sequence number of the reports submitted during
the year, starting with 00001. (For example, the complete number will
appear 1234567-1995-00001.)
(q) MDR means medical device report.
(r) MDR reportable event (or reportable event) means:
(1) An event about which user facilities become aware of information
that reasonably suggests that a device has or may have caused or
contributed to a death or serious injury; or
(2) An event about which manufacturers or importers have received or
become aware of information that reasonably suggests that one of their
marketed devices:
(i) May have caused or contributed to a death or serious injury; or
(ii) Has malfunctioned and that the device or a similar device
marketed by the manufacturer or importer would be likely to cause or
contribute to a death or serious injury if the malfunction were to
recur.
(s) Medical personnel, as used in this part, means an individual
who:
(1) Is licensed, registered, or certified by a State, territory, or
other governing body, to administer health care;
(2) Has received a diploma or a degree in a professional or
scientific discipline;
(3) Is an employee responsible for receiving medical complaints or
adverse event reports; or
(4) Is a supervisor of such persons.
(t)(1) Nursing home means an independent entity (i.e., not a part of
a provider of services or any other facility) or one operated by another
medical entity (e.g., under the common ownership, licensure, or control
of an entity) that operates for the primary purpose of providing:
(i) Skilled nursing care and related services for persons who
require medical or nursing care;
(ii) Hospice care to the terminally ill; or
(iii) Services for the rehabilitation of the injured, disabled, or
sick.
(2) A nursing home is subject to this regulation regardless of
whether it is licensed by a Federal, State, municipal, or local
government or whether it is accredited by a recognized accreditation
organization. If an adverse event meets the criteria for reporting, the
nursing home must report that event regardless of the nature, or
location of the medical service provided by the nursing home.
(u)(1) Outpatient diagnostic facility means a distinct entity that:
(i) Operates for the primary purpose of conducting medical
diagnostic tests on patients;
(ii) Does not assume ongoing responsibility for patient care; and
(iii) Provides its services for use by other medical personnel.
(Examples include diagnostic radiography, mammography, ultrasonography,
electrocardiography, magnetic resonance imaging, computerized axial
tomography and in-vitro testing).
(2) An outpatient diagnostic facility may be either independent
(i.e., not a part of a provider of services or any
[[Page 42]]
other facility) or operated by another medical entity (e.g., under the
common ownership, licensure, or control of an entity). An outpatient
diagnostic facility is covered by this regulation regardless of whether
it is licensed by a Federal, State, municipal, or local government or
whether it is accredited by a recognized accreditation organization. If
an adverse event meets the criteria for reporting, the outpatient
diagnostic facility must report that event regardless of the nature or
location of the medical service provided by the outpatient diagnostic
facility.
(v)(1) Outpatient treatment facility means a distinct entity that
operates for the primary purpose of providing nonsurgical therapeutic
(medical, occupational, or physical) care on an outpatient basis or home
health care setting. Outpatient treatment facilities include ambulance
providers, rescue services, and home health care groups. Examples of
services provided by outpatient treatment facilities include: Cardiac
defibrillation, chemotherapy, radiotherapy, pain control, dialysis,
speech or physical therapy, and treatment for substance abuse.
(2) An outpatient treatment facility may be either independent
(i.e., not a part of a provider of services or any other facility) or
operated by another medical entity (e.g., under the common ownership,
licensure, or control of an entity). An outpatient treatment facility is
covered by this regulation regardless of whether it is licensed by a
Federal, State, municipal, or local government or whether it is
accredited by a recognized accreditation organization. If an adverse
event meets the criteria for reporting, the outpatient treatment
facility must report that event regardless of the nature or location of
the medical service provided by the outpatient treatment facility.
(w) Patient of the facility means any individual who is being
diagnosed or treated and/or receiving medical care at or under the
control or authority of the facility. For the purposes of this part, the
definition encompasses employees of the facility or individuals
affiliated with the facility, who in the course of their duties suffer a
device-related death or serious injury that has or may have been caused
or contributed to by a device used at the facility.
(x) Physician's office means a facility that operates as the office
of a physician or other health care professional (e.g., dentist,
chiropractor, optometrist, nurse practitioner, school nurse offices,
school clinics, employee health clinics, or free-standing care units)
for the primary purpose of examination, evaluation, and treatment or
referral of patients. A physician's office may be independent, a group
practice, or part of a Health Maintenance Organization.
(y) [Reserved]
(z) Remedial action means, for the purposes of this subpart, any
action other than routine maintenance or servicing, of a device where
such action is necessary to prevent recurrence of a reportable event.
(aa) [Reserved]
(bb)(1) Serious injury means an injury or illness that:
(i) Is life-threatening;
(ii) Results in permanent impairment of a body function or permanent
damage to body structure; or
(iii) Necessitates medical or surgical intervention to preclude
permanent impairment of a body function or permanent damage to a body
structure.
(2) Permanent means, for purposes of this subpart, irreversible
impairment or damage to a body structure or function, excluding trivial
impairment or damage.
(cc) Shelf life, as required on the manufacturer's baseline report,
means the maximum time a device will remain functional from the date of
manufacture until it is used in patient care. Some devices have an
expiration date on their labeling indicating the maximum time they can
be stored before losing their ability to perform their intended
function.
(dd) [Reserved]
(ee)(1) User facility report number means the number that uniquely
identifies each report submitted by a user facility to manufacturers and
FDA. This number consists of three parts as follows:
(i) The user facility's 10-digit Health Care Financing
Administration (HCFA) number (if the HCFA number has fewer than 10
digits, fill the remaining spaces with zeros);
[[Page 43]]
(ii) The four-digit calendar year in which the report is submitted;
and
(iii) The four-digit sequence number of the reports submitted for
the year, starting with 0001. (For example, a complete number will
appear as follows: 1234560000-1995-0001.)
(2) If a facility has more than one HCFA number, it must select one
that will be used for all of its MDR reports. If a facility has no HCFA
number, it should use all zeros in the appropriate space in its initial
report (e.g., 0000000000-1995-0001) and FDA will assign a number for
future use. The number assigned will be used in FDA's record of that
report and in any correspondence with the user facility. All zeros
should be used subsequent to the first report if the user does not
receive FDA's assigned number before the next report is submitted. If a
facility has multiple sites, the primary site can report centrally and
use one reporting number for all sites if the primary site provides the
name, address and HCFA number for each respective site.
(ff) Work day means Monday through Friday, excluding Federal
holidays.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4118, Jan. 26, 2000; 66
FR 23156, May 8, 2001]
Effective Date Note: At 61 FR 38347, July 23, 1996, in Sec. 803.3,
paragraph (n)(4) was stayed indefinitely.
Sec. 803.9 Public availability of reports.
(a) Any report, including any FDA record of a telephone report,
submitted under this part is available for public disclosure in
accordance with part 20 of this chapter.
(b) Before public disclosure of a report, FDA will delete from the
report:
(1) Any information that constitutes trade secret or confidential
commercial or financial information under Sec. 20.61 of this chapter;
(2) Any personal, medical, and similar information (including the
serial number of implanted devices), which would constitute an invasion
of personal privacy under Sec. 20.63 of this chapter. FDA will disclose
to a patient who requests a report, all the information in the report
concerning that patient, as provided in Sec. 20.61 of this chapter; and
(3) Any names and other identifying information of a third party
voluntarily submitting an adverse event report.
(c) FDA may not disclose the identity of a device user facility
which makes a report under this part except in connection with:
(1) An action brought to enforce section 301(q) of the act,
including the failure or refusal to furnish material or information
required by section 519 of the act;
(2) A communication to a manufacturer of a device which is the
subject of a report required by a user facility under Sec. 803.30; or
(3) A disclosure to employees of the Department of Health and Human
Services, to the Department of Justice, or to the duly authorized
committees and subcommittees of the Congress.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]
Sec. 803.10 General description of reports required from user
facilities, importers, and manufacturers.
(a) Device user facilities. User facilities must submit the
following reports, which are described more fully in subpart C of this
part.
(1) User facilities must submit MDR reports of individual adverse
events within 10 days after the user facility becomes aware of an MDR
reportable event as described in Secs. 803.30 and 803.32.
(i) User facilities must submit reports of device-related deaths to
FDA and to the manufacturer, if known.
(ii) User facilities must submit reports of device-related serious
injuries to manufacturers, or to FDA, if the manufacturer is unknown.
(2) User facilities must submit annual reports as described in
Sec. 803.33.
(b) Device importers. Importers must submit the following reports,
which are described more fully in subpart D of this part.
(1) Importers must submit MDR reports of individual adverse events
within 30 days after the importer becomes aware of an MDR reportable
event as described in Secs. 803.40 and 803.42.
(i) Importers must submit reports of device-related deaths or
serious injuries to FDA and to the manufacturer.
[[Page 44]]
(ii) Importers must submit reports of malfunctions to the
manufacturer.
(2) [Reserved]
(c) Device manufacturers. Manufacturers must submit the following
reports as described more fully in subpart E of this part:
(1) MDR reports of individual adverse events within 30 days after
the manufacturer becomes aware of a reportable death, serious injury, or
malfunction as described in Secs. 803.50 and 803.52.
(2) MDR reports of individual adverse events within 5 days of:
(i) Becoming aware that a reportable MDR event requires remedial
action to prevent an unreasonable risk of substantial harm to the public
health or,
(ii) Becoming aware of an MDR reportable event for which FDA has
made a written request, as described in Sec. 803.53.
(3) Annual baseline reports as described in Sec. 803.55.
(4) Supplemental reports if they obtain information that was not
provided in an initial report as described in Sec. 803.56.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000; 66
FR 23157, May 8, 2001]
Sec. 803.11 Obtaining the forms.
User facilities and manufacturers must submit all reports of
individual adverse events on FDA Form 3500A (MEDWATCH form) or in an
electronic equivalent as approved under Sec. 803.14. This form and all
other forms referenced in this section can also be obtained from the
Consolidated Forms and Publications Office, Washington Commerce Center,
3222 Hubbard Rd., Landover, MD 20875; from the Food and Drug
Administration, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857,
301-827-7240; from the Division of Small Manufacturers Assistance,
Office of Health and Industry Programs, Center for Devices and
Radiological Health (HFZ-220), 1350 Piccard Dr. Rockville, MD 20850, FAX
301-443-8818; or from http://www.fda.gov/opacom/morechoices/fdaforms/
cdrh.html on the Internet.
[65 FR 17136, Mar. 31, 2000]
Sec. 803.12 Where to submit reports.
(a) Any written report or additional information required under this
part shall be submitted to: Food and Drug Administration, Center for
Devices and Radiological Health, Medical Device Reporting, PO Box 3002,
Rockville, MD 20847-3002.
(b) Each report and its envelope shall be specifically identified,
e.g., ``User Facility Report,'' ``Annual Report,'' ``Importer Report,''
``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.
(c) If an entity is confronted with a public health emergency, this
can be brought to FDA's attention by contacting the FDA Emergency
Operations Branch (HFC-162), Office of Regional Operations, at 301-443-
1240, and should be followed by the submission of a FAX report to 301-
443-3757.
(d) A voluntary telephone report may be submitted to, or information
regarding voluntary reporting may be obtained from, the MEDWATCH hotline
at 800-FDA-1088.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]
Sec. 803.13 English reporting requirement.
(a) All reports required in this part which are submitted in writing
or electronic equivalent shall be submitted to FDA in English.
(b) All reports required in this part which are submitted on an
electronic medium shall be submitted to FDA in a manner consistent with
Sec. 803.14.
Sec. 803.14 Electronic reporting.
(a) Any report required by this part may be submitted electronically
with prior written consent from FDA. Such consent is revocable.
Electronic report submissions include alternative reporting media
(magnetic tape, disc, etc.) and computer-to-computer communication.
(b) Any electronic report meeting electronic reporting standards,
guidance documents, or other procedures developed by the agency for MDR
reporting will be deemed to have prior approval for use.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 56480, Sept. 19, 2000]
[[Page 45]]
Sec. 803.15 Requests for additional information.
(a) FDA may determine that protection of the public health requires
additional or clarifying information for medical device reports
submitted to FDA under this part. In these instances, and in cases when
the additional information is beyond the scope of FDA reporting forms or
is not readily accessible, the agency will notify the reporting entity
in writing of the additional information that is required.
(b) Any request under this section shall state the reason or purpose
for which the information is being requested, specify the date that the
information is to be submitted and clearly relate the request to a
reported event. All verbal requests will be confirmed in writing by the
agency.
Sec. 803.16 Disclaimers.
A report or other information submitted by a reporting entity under
this part, and any release by FDA of that report or information, does
not necessarily reflect a conclusion by the party submitting the report
or by FDA that the report or information constitutes an admission that
the device, or the reporting entity or its employees, caused or
contributed to the reportable event. The reporting entity need not admit
and may deny that the report or information submitted under this part
constitutes an admission that the device, the party submitting the
report, or employees thereof, caused or contributed to a reportable
event.
Sec. 803.17 Written MDR procedures.
User facilities, importers, and manufacturers shall develop,
maintain, and implement written MDR procedures for the following:
(a) Internal systems that provide for:
(1) Timely and effective identification, communication, and
evaluation of events that may be subject to medical device reporting
requirements;
(2) A standardized review process/procedure for determining when an
event meets the criteria for reporting under this part; and
(3) Timely transmission of complete medical device reports to FDA
and/or manufacturers;
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was
reportable;
(2) All medical device reports and information submitted to FDA and
manufacturers;
(3) Any information that was evaluated for the purpose of preparing
the submission of annual reports; and
(4) Systems that ensure access to information that facilitates
timely followup and inspection by FDA.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000; 66
FR 23157, May 8, 2001]
Sec. 803.18 Files and distributor records.
(a) User facilities, importers, and manufacturers shall establish
and maintain MDR event files. All MDR event files shall be prominently
identified as such and filed to facilitate timely access.
(b)(1) For purposes of this part, ``MDR event files'' are written or
electronic files maintained by user facilities, importers, and
manufacturers. MDR event files may incorporate references to other
information, e.g., medical records, patient files, engineering reports,
etc., in lieu of copying and maintaining duplicates in this file. MDR
event files must contain:
(i) Information in the possession of the reporting entity or
references to information related to the adverse event, including all
documentation of the entity's deliberations and decisionmaking processes
used to determine if a device-related death, serious injury, or
malfunction was or was not reportable under this part.
(ii) Copies of all MDR forms, as required by this part, and other
information related to the event that was submitted to FDA and other
entities (e.g., an importer, distributor, or manufacturer).
(2) User facilities, importers, and manufacturers shall permit any
authorized FDA employee during all reasonable times to access, to copy,
and to verify the records required by this part.
(c) User facilities shall retain an MDR event file relating to an
adverse event for a period of 2 years from the date of the event.
Manufacturers and
[[Page 46]]
importers shall retain an MDR event file relating to an adverse event
for a period of 2 years from the date of the event or a period of time
equivalent to the expected life of the device, whichever is greater. MDR
event files must be maintained for the time periods described in this
paragraph even if the device is no longer distributed.
(d)(1) A device distributor shall establish and maintain device
complaint records containing any incident information, including any
written, electronic, or oral communication, either received by or
generated by the firm, that alleges deficiencies related to the identity
(e.g., labeling), quality, durability, reliability, safety,
effectiveness, or performance of a device. Information regarding the
evaluation of the allegations, if any, shall also be maintained in the
incident record. Device incident records shall be prominently identified
as such and shall be filed by device, and may be maintained in written
or electronic form. Files maintained in electronic form must be backed
up.
(2) A device distributor shall retain copies of the records required
to be maintained under this section for a period of 2 years from the
date of inclusion of the record in the file or for a period of time
equivalent to the expected life of the device, whichever is greater,
even if the distributor has ceased to distribute the device that is the
subject of the record.
(3) A device distributor shall maintain the device complaint files
established under this section at the distributor's principal business
establishment. A distributor that is also a manufacturer may maintain
the file at the same location as the manufacturer maintains its
complaint file under Secs. 820.180 and 820.198 of this chapter. A device
distributor shall permit any authorized FDA employee, during all
reasonable times, to have access to, and to copy and verify, the records
required by this part.
(e) The manufacturer may maintain MDR event files as part of its
complaint file, under Sec. 820.198 of this chapter, provided that such
records are prominently identified as MDR reportable events. A report
submitted under this subpart A shall not be considered to comply with
this part unless the event has been evaluated in accordance with the
requirements of Secs. 820.162 and 820.198 of this chapter. MDR files
shall contain an explanation of why any information required by this
part was not submitted or could not be obtained. The results of the
evaluation of each event are to be documented and maintained in the
manufacturer's MDR event file.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]
Sec. 803.19 Exemptions, variances, and alternative reporting
requirements.
(a) The following persons are exempt from the reporting requirements
under this part.
(1) An individual who is a licensed practitioner who prescribes or
administers devices intended for use in humans and who manufactures or
imports devices solely for use in diagnosing and treating persons with
whom the practitioner has a ``physician-patient'' relationship.
(2) An individual who manufactures devices intended for use in
humans solely for such person's use in research or teaching and not for
sale, including any person who is subject to alternative reporting
requirements under the investigational device exemption regulations,
part 812 of this chapter, which require reporting of all adverse device
effects.
(3) Dental laboratories, or optical laboratories.
(b) Manufacturers, importers, or user facilities may request
exemptions or variances from any or all of the reporting requirements in
this part. The request shall be in writing and include information
necessary to identify the firm and device, a complete statement of the
request for exemption, variance, or alternative reporting, and an
explanation why the request is justified.
(c) FDA may grant in writing, to a manufacturer, importer, or user
facility, an exemption, variance, or alternative from, or to, any or all
of the reporting requirements in this part and may change the frequency
of reporting to quarterly, semiannually, annually, or other appropriate
time period. These modifications may be initiated by a request as
specified in this section, or at
[[Page 47]]
the discretion of FDA. When granting such modifications, FDA may impose
other reporting requirements to ensure the protection of public health.
(d) FDA may revoke or modify in writing an exemption, variance, or
alternative reporting requirements if FDA determines that protection of
the public health justifies the modification or a return to the
requirements as stated in this part.
(e) Firms granted a reporting modification by FDA shall provide any
reports or information required by that approval. The conditions of the
approval will replace and supersede the reporting requirement specified
in this part until such time that FDA revokes or modifies the
alternative reporting requirements in accordance with paragraph (d) of
this section.
[60 FR 63597, Dec. 11, 1995, as amended at 61 FR 44615, Aug. 28, 1996;
65 FR 4119, Jan. 26, 2000; 65 FR 17136, Mar. 31, 2000; 66 FR 23157, May
8, 2001]
Subpart B--Generally Applicable Requirements for Individual Adverse
Event Reports
Sec. 803.20 How to report.
(a) Description of form. There are two versions of the MEDWATCH form
for individual reports of adverse events. FDA Form 3500 is available for
use by health professionals and consumers for the submission of
voluntary reports regarding FDA-regulated products. FDA Form 3500A is
the mandatory reporting form to be used for submitting reports by user
facilities, importers, and manufacturers of FDA-regulated products. The
form has some sections that must be completed by all reporters and other
sections that must be completed only by the user facility, importer, or
manufacturer.
(1) The front of FDA Form 3500A is to be filled out by all
reporters. The front of the form requests information regarding the
patient, the event, the device, and the ``initial reporter'' (i.e., the
first person or entity that submitted the information to the user
facility, manufacturer, or importer).
(2) The back part of the form contains sections to be completed by
user facilities, importers, and manufacturers. User facilities and
importers must complete section F; device manufacturers must complete
sections G and H. Manufacturers are not required to recopy information
submitted to them on a Form 3500A unless the information is being copied
onto an electronic medium. If the manufacturer corrects or supplies
information missing from the other reporter's 3500A form, it should
attach a copy of that form to the manufacturer's report form. If the
information from the other reporter's 3500A form is complete and
correct, the manufacturer can fill in the remaining information on the
same form.
(b) Reporting standards. (1) User facilities are required to submit
MDR reports to:
(i) The device manufacturer and to FDA within 10 days of becoming
aware of information that reasonably suggests that a device has or may
have caused or contributed to a death; or
(ii) The manufacturer within 10 days of becoming aware of
information that reasonably suggests that a device has or may have
caused or contributed to a serious injury. Such reports shall be
submitted to FDA if the device manufacturer is not known.
(2) Importers are required to submit death and serious injury
reports to FDA and the device manufacturer and submit malfunction
reports to the manufacturer only:
(i) Within 30 days of becoming aware of information that reasonably
suggests that a device has or may have caused or contributed to a death
or serious injury.
(ii) Within 30 days of receiving information that a device marketed
by the importer has malfunctioned and that such a device or a similar
device marketed by the importer would be likely to cause or contribute
to a death or serious injury if the malfunction were to recur.
(3) Manufacturers are required to submit MDR reports to FDA:
(i) Within 30 days of becoming aware of information that reasonably
suggests that a device may have caused or contributed to a death or
serious injury; or
(ii) Within 30 days of becoming aware of information that reasonably
suggests a device has malfunctioned and
[[Page 48]]
that device or a similar device marketed by the manufacturer would be
likely to cause a death or serious injury if the malfunction were to
recur; or
(iii) Within 5 days if required by Sec. 803.53.
(c) Information that reasonably suggests a reportable event
occurred. (1) Information that reasonably suggests that a device has or
may have caused or contributed to an MDR reportable event (i.e., death,
serious injury, and, for manufacturers and importers, a malfunction that
would be likely to cause or contribute to a death or serious injury if
the malfunction were to recur) includes any information, such as
professional, scientific or medical facts and observations or opinions,
that would reasonably suggest that a device has caused or may have
caused or contributed to a reportable event.
(2) Entities required to report under this part do not have to
report adverse events for which there is information that would cause a
person who is qualified to make a medical judgment (e.g., a physician,
nurse, risk manager, or biomedical engineer) to reach a reasonable
conclusion that a device did not cause or contribute to a death or
serious injury, or that a malfunction would not be likely to cause or
contribute to a death or serious injury if it were to recur. Information
which leads the qualified person to determine that a device-related
event is or is not reportable must be contained in the MDR event files,
as described in Sec. 803.18.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000; 66
FR 23157, May 8, 2001]
Sec. 803.21 Reporting codes.
(a) FDA has developed a MEDWATCH Mandatory Reporting Form Coding
Manual for use with medical device reports. This manual contains codes
for hundreds of adverse events for use with FDA Form 3500A. The coding
manual is available from the Division of Small Manufacturer Assistance,
Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville,
MD 20850, FAX 301-443-8818.
(b) FDA may use additional coding of information on the reporting
forms or modify the existing codes on an ad hoc or generic basis. In
such cases, FDA will ensure that the new coding information is available
to all reporters.
Sec. 803.22 When not to file.
(a) Only one medical device report from the user facility, importer,
or manufacturer is required under this part if the reporting entity
becomes aware of information from multiple sources regarding the same
patient and same event.
(b) A medical device report that would otherwise be required under
this section is not required if:
(1) The user facility, importer, or manufacturer determines that the
information received is erroneous in that a device-related adverse event
did not occur. Documentation of such reports shall be retained in MDR
files for time periods specified in Sec. 803.18.
(2) The manufacturer or importer determines that the device was
manufactured or imported by another manufacturer or importer. Any
reportable event information that is erroneously sent to a manufacturer
or importer shall be forwarded to FDA, with a cover letter explaining
that the device in question was not manufactured or imported by that
firm.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4120, Jan. 26, 2000]
Subpart C--User Facility Reporting Requirements
Sec. 803.30 Individual adverse event reports; user facilities.
(a) Reporting standard. A user facility shall submit the following
reports to the manufacturer or to FDA, or both, as specified below:
(1) Reports of death. Whenever a user facility receives or otherwise
becomes aware of information, from any source, that reasonably suggests
that a device has or may have caused or contributed to the death of a
patient of the facility, the facility shall as soon as practicable, but
not later than 10 work days after becoming aware of the information,
report the information required by Sec. 803.32 to FDA, on FDA Form
3500A, or an electronic equivalent as approved under Sec. 803.14, and if
the identity of the
[[Page 49]]
manufacturer is known, to the device manufacturer.
(2) Reports of serious injury. Whenever a user facility receives or
otherwise becomes aware of information, from any source, that reasonably
suggests that a device has or may have caused or contributed to a
serious injury to a patient of the facility, the facility shall, as soon
as practicable but not later than 10 work days after becoming aware of
the information, report the information required by Sec. 803.32, on FDA
Form 3500A or electronic equivalent, as approved under Sec. 803.14, to
the manufacturer of the device. If the identity of the manufacturer is
not known, the report shall be submitted to FDA.
(b) Information that is reasonably known to user facilities. User
facilities must provide all information required in this subpart C that
is reasonably known to them. Such information includes information found
in documents in the possession of the user facility and any information
that becomes available as a result of reasonable followup within the
facility. A user facility is not required to evaluate or investigate the
event by obtaining or evaluating information that is not reasonably
known to it.
Sec. 803.32 Individual adverse event report data elements.
User facility reports shall contain the following information,
reasonably known to them as described in 803.30(b), which corresponds to
the format of FDA Form 3500A:
(a) Patient information (Block A) shall contain the following:
(1) Patient name or other identifier;
(2) Patient age at the time of event, or date of birth;
(3) Patient gender; and
(4) Patient weight.
(b) Adverse event or product problem (Block B) shall contain the
following:
(1) Identification of adverse event or product problem;
(2) Outcomes attributed to the adverse event, e.g., death; or
serious injury, that is:
(i) Life threatening injury or illness;
(ii) Disability resulting in permanent impairment of a body function
or permanent damage to a body structure; or
(iii) Injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
(3) Date of event;
(4) Date of report by the initial reporter;
(5) Description of event or problem, including a discussion of how
the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
(6) Description of relevant tests including dates and laboratory
data; and
(7) Description of other relevant history including pre- existing
medical conditions.
(c) Device information (Block D) shall contain the following:
(1) Brand name;
(2) Type of device;
(3) Manufacturer name and address;
(4) Operator of the device (health professional, patient, lay user,
other);
(5) Expiration date;
(6) Model number, catalog number, serial number, lot number, or
other identifying number;
(7) Date of device implantation (month, day, year);
(8) Date of device explantation (month, day, year);
(9) Whether device was available for evaluation and whether device
was returned to the manufacturer; if so, the date it was returned to the
manufacturer; and
(10) Concomitant medical products and therapy dates. (Do not list
products that were used to treat the event.)
(d) Initial reporter information (Block E) shall contain the
following:
(1) Name, address, and telephone number of the reporter who
initially provided information to the user facility, manufacturer, or
distributor;
(2) Whether the initial reporter is a health professional;
(3) Occupation; and
(4) Whether initial reporter also sent a copy of the report to FDA,
if known.
(e) User facility information (Block F) shall contain the following:
(1) Whether reporter is a user facility;
(2) User facility number;
(3) User facility address;
[[Page 50]]
(4) Contact person;
(5) Contact person's telephone number;
(6) Date the user facility became aware of the event (month, day,
year);
(7) Type of report (initial or followup (if followup, include report
number of initial report));
(8) Date of the user facility report (month, day, year);
(9) Approximate age of device;
(10) Event problem codes--patient code and device code (refer to FDA
``Coding Manual For Form 3500A'');
(11) Whether a report was sent to FDA and the date it was sent
(month, day, year);
(12) Location, where event occurred;
(13) Whether report was sent to the manufacturer and the date it was
sent (month, day, year); and
(14) Manufacturer name and address; if available.
Sec. 803.33 Annual reports.
(a) Each user facility shall submit to FDA an annual report on FDA
Form 3419, or electronic equivalent as approved by FDA under
Sec. 803.14. Annual reports shall be submitted by January 1 of each
year. The annual report and envelope shall be clearly identified and
submitted to FDA with information that includes:
(1) User facility's HCFA provider number used for medical device
reports, or number assigned by FDA for reporting purposes in accordance
with Sec. 803.3(ee);
(2) Reporting year;
(3) Facility's name and complete address;
(4) Total number of reports attached or summarized;
(5) Date of the annual report and the lowest and highest user
facility report number of medical device reports submitted during the
report period, e.g., 1234567890-1995-0001 through 1000;
(6) Name, position title, and complete address of the individual
designated as the facility contact person responsible for reporting to
FDA and whether that person is a new contact for that facility; and
(7) Information for each reportable event that occurred during the
annual reporting period including:
(i) User facility report number;
(ii) Name and address of the device manufacturer;
(iii) Device brand name and common name;
(iv) Product model, catalog, serial and lot number;
(v) A brief description of the event reported to the manufacturer
and/or FDA; and
(vi) Where the report was submitted, i.e., to FDA, manufacturer,
distributor, importer, etc.
(b) In lieu of submitting the information in paragraph (a)(7) of
this section, a user facility may submit a copy of FDA Form 3500A, or an
electronic equivalent as approved under section 803.14, for each medical
device report submitted to FDA and/or manufacturers by that facility
during the reporting period.
(c) If no reports are submitted to either FDA or manufacturers
during these time periods, no annual report is required.
[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4120, Jan. 26, 2000]
Subpart D--Importer Reporting Requirements
Source: 65 FR 4120, Jan. 26, 2000, unless otherwise noted.
Sec. 803.40 Individual adverse event reporting requirements; importers.
(a) An importer shall submit to FDA a report, and a copy of such
report to the manufacturer, containing the information required by
Sec. 803.42 on FDA form 3500A as soon as practicable, but not later than
30 days after the importer receives or otherwise becomes aware of
information from any source, including user facilities, individuals, or
medical or scientific literature, whether published or unpublished, that
reasonably suggests that one of its marketed devices may have caused or
contributed to a death or serious injury.
(b) An importer shall submit to the manufacturer a report containing
information required by Sec. 803.42 on FDA form 3500A, as soon as
practicable, but not later than 30 days after the importer receives or
otherwise becomes aware of information from any source, including user
facilities, individuals, or
[[Page 51]]
through the importer's own research, testing, evaluation, servicing, or
maintenance of one of its devices, that one of the devices marketed by
the importer has malfunctioned and that such device or a similar device
marketed by the importer would be likely to cause or contribute to a
death or serious injury if the malfunction were to recur.
Sec. 803.42 Individual adverse event report data elements.
Individual medical device importer reports shall contain the
following information, in so far as the information is known or should
be known to the importer, as described in Sec. 803.40, which corresponds
to the format of FDA Form 3500A:
(a) Patient information (Block A) shall contain the following:
(1) Patient name or other identifier;
(2) Patient age at the time of event, or date of birth;
(3) Patient gender; and
(4) Patient weight.
(b) Adverse event or product problem (Block B) shall contain the
following:
(1) Adverse event or product problem;
(2) Outcomes attributed to the adverse event, that is:
(i) Death;
(ii) Life threatening injury or illness;
(iii) Disability resulting in permanent impairment of a body
function or permanent damage to a body structure; or
(iv) Injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
(3) Date of event;
(4) Date of report by the initial reporter;
(5) Description of the event or problem to include a discussion of
how the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
(6) Description of relevant tests, including dates and laboratory
data; and
(7) Other relevant patient history including preexisting medical
conditions.
(c) Device information (Block D) shall contain the following:
(1) Brand name;
(2) Type of device;
(3) Manufacturer name and address;
(4) Operator of the device (health professional, patient, lay user,
other);
(5) Expiration date;
(6) Model number, catalog number, serial number, lot number or other
identifying number;
(7) Date of device implantation (month, day, year);
(8) Date of device explantation (month, day, year);
(9) Whether the device was available for evaluation, and whether the
device was returned to the manufacturer, and if so, the date it was
returned to the manufacturer; and
(10) Concomitant medical products and therapy dates. (Do not list
products that were used to treat the event.)
(d) Initial reporter information (Block E) shall contain the
following:
(1) Name, address, and phone number of the reporter who initially
provided information to the user facility, manufacturer, or distributor;
(2) Whether the initial reporter is a health professional;
(3) Occupation; and
(4) Whether the initial reporter also sent a copy of the report to
FDA, if known.
(e) Importer information (Block F) shall contain the following:
(1) Whether reporter is an importer;
(2) Importer report number;
(3) Importer address;
(4) Contact person;
(5) Contact person's telephone number;
(6) Date the importer became aware of the event (month, day, year);
(7) Type of report (initial or followup (if followup, include report
number of initial report));
(8) Date of the importer report (month, day, year);
(9) Approximate age of device;
(10) Event problem codes--patient code and device code (refer to FDA
``Coding Manual For Form 3500A'');
(11) Whether a report was sent to FDA and the date it was sent
(month, day, year);
(12) Location, where event occurred;
(13) Whether a report was sent to the manufacturer and the date it
was sent (month, day, year); and
(14) Manufacturer name and address; if available.
[[Page 52]]
Subpart E--Manufacturer Reporting Requirements
Sec. 803.50 Individual adverse event reports; manufacturers.
(a) Reporting standards. Device manufacturers are required to report
within 30 days whenever the manufacturer receives or otherwise becomes
aware of information, from any source, that reasonably suggests that a
device marketed by the manufacturer:
(1) May have caused or contributed to a death or serious injury; or
(2) Has malfunctioned and such device or similar device marketed by
the manufacturer would be likely to cause or contribute to a death or
serious injury, if the malfunction were to recur.
(b) Information that is reasonably known to manufacturers. (1)
Manufacturers must provide all information required in this subpart E
that is reasonably known to them. FDA considers the following
information to be reasonably known to the manufacturer:
(i) Any information that can be obtained by contacting a user
facility, importer, or other initial reporter;
(ii) Any information in a manufacturer's possession; or
(iii) Any information that can be obtained by analysis, testing or
other evaluation of the device.
(2) Manufacturers are responsible for obtaining and providing FDA
with information that is incomplete or missing from reports submitted by
user facilities, importers, and other initial reporters. Manufacturers
are also responsible for conducting an investigation of each event and
evaluating the cause of the event. If a manufacturer cannot provide
complete information on an MDR report, it must provide a statement
explaining why such information was incomplete and the steps taken to
obtain the information. Any required information not available at the
time of the report, which is obtained after the initial filing, must be
provided by the manufacturer in a supplemental report under Sec.
803.56.
[60 FR 63597, Dec. 11, 1995, as amended at 66 FR 23157, May 8, 2001]
Sec. 803.52 Individual adverse event report data elements.
Individual medical device manufacturer reports shall contain the
following information, known or reasonably known to them as described in
Sec. 803.50(b), which corresponds to the format of FDA Form 3500A:
(a) Patient information (Block A) shall contain the following:
(1) Patient name or other identifier;
(2) Patient age at the time of event, or date of birth;
(3) Patient gender; and
(4) Patient weight.
(b) Adverse event or product problem (Block B) shall contain the
following:
(1) Adverse event or product problem;
(2) Outcomes attributed to the adverse event, e.g., death; or
serious injury, that is:
(i) Life threatening injury or illness;
(ii) Disability resulting in permanent impairment of a body function
or permanent damage to a body structure; or
(iii) Injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
(3) Date of event;
(4) Date of report by the initial reporter;
(5) Description of the event or problem to include a discussion of
how the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
(6) Description of relevant tests, including dates and laboratory
data; and
(7) Other relevant patient history including pre-existing medical
conditions.
(c) Device information (Block D) shall contain the following:
(1) Brand name;
(2) Type of device;
(3) Manufacturer name and address;
(4) Operator of the device (health professional, patient, lay user,
other);
(5) Expiration date;
(6) Model number, catalog number, serial number, lot number or other
identifying number;
(7) Date of device implantation (month, day, year);
(8) Date of device explantation (month, day, year);
[[Page 53]]
(9) Whether the device was available for evaluation, and whether the
device was returned to the manufacturer, and if so, the date it was
returned to the manufacturer; and
(10) Concomitant medical products and therapy dates. (Do not list
products that were used to treat the event.)
(d) Initial reporter information (Block E) shall contain the
following:
(1) Name, address, and phone number of the reporter who initially
provided information to the user facility, manufacturer, or importer;
(2) Whether the initial reporter is a health professional;
(3) Occupation; and
(4) Whether the initial reporter also sent a copy of the report to
FDA, if known.
(e) All manufacturers (Block G) shall contain the following:
(1) Contact office name and address and device manufacturing site;
(2) Telephone number;
(3) Report sources;
(4) Date received by manufacturer (month, day, year);
(5) Type of report being submitted (e.g., 5-day, initial,
supplemental); and
(6) Manufacturer report number.
(f) Device manufacturers (Block H) shall contain the following:
(1) Type of reportable event (death, serious injury, malfunction,
etc.);
(2) Type of followup report, if applicable (e.g., correction,
response to FDA request, etc.);
(3) If the device was returned to the manufacturer and evaluated by
the manufacturer, a summary of the evaluation. If no evaluation was
performed, provide an explanation why no evaluation was performed;
(4) Device manufacture date (month, day, year);
(5) Was device labeled for single use;
(6) Evaluation codes (including event codes, method of evaluation,
result, and conclusion codes) (refer to FDA ``Coding Manual for Form
3500A'');
(7) Whether remedial action was taken and type;
(8) Whether use of device was initial, reuse, or unknown;
(9) Whether remedial action was reported as a removal or correction
under section 519(f) of the act (list the correction/removal report
number); and
(10) Additional manufacturer narrative; and/or
(11) Corrected data, including:
(i) Any information missing on the user facility report or importer
report, including missing event codes, or information corrected on such
forms after manufacturer verification;
(ii) For each event code provided by the user facility under
Sec. 803.32(e)(10) or the importer under Sec. 803.42(e)(10), a
statement of whether the type of event represented by the code is
addressed in the device labeling; and
(iii) If any required information was not provided, an explanation
of why such information was not provided and the steps taken to obtain
such information.
[60 FR 63597, Dec. 11, 1995, as amended at 66 FR 23157, May 8, 2001]
Sec. 803.53 Five-day reports.
A manufacturer shall submit a 5-day report to FDA, on Form 3500A or
electronic equivalent as approved by FDA under Sec. 803.14 within 5
workdays of:
(a) Becoming aware that a reportable MDR event or events, from any
information, including any trend analysis, necessitates remedial action
to prevent an unreasonable risk of substantial harm to the public
health; or
(b) Becoming aware of an MDR reportable event for which FDA has made
a written request for the submission of a 5-day report. When such a
request is made, the manufacturer shall submit, without further
requests, a 5-day report for all subsequent events of the same nature
that involve substantially similar devices for the time period specified
in the written request. The time period stated in the original written
request can be extended by FDA if it is in the interest of the public
health.
Sec. 803.55 Baseline reports.
(a) A manufacturer shall submit a baseline report on FDA Form 3417,
or electronic equivalent as approved by FDA under Sec. 803.14 for a
device when the device model is first reported under Sec. 803.50.
(b) Each baseline report shall be updated annually, on the
anniversary month of the initial submission, after the initial baseline
report is submitted.
[[Page 54]]
Changes to baseline information shall be reported in the manner
described in Sec. 803.56 (i.e., include only the new, changed, or
corrected information in the appropriate portion(s) of the report form).
Baseline reports shall contain the following:
(1) Name, complete address, and registration number of the
manufacturer's reporting site. If the reporting site is not registered,
FDA will assign a temporary registration number until the reporting site
officially registers. The manufacturer will be informed of the temporary
registration number;
(2) FDA registration number of each site where the device is
manufactured;
(3) Name, complete address, and telephone number of the individual
who has been designated by the manufacturer as its MDR contact and date
of the report. For foreign manufacturers, a confirmation that the
individual submitting the report is the agent of the manufacturer
designated under Sec. 803.58(a) is required;
(4) Product identification, including device family, brand name,
generic name, model number, catalog number, product code and any other
product identification number or designation;
(5) Identification of any device previously reported in a baseline
report that is substantially similar (e.g., same device with a different
model number, or same device except for cosmetic differences in color or
shape) to the device being reported, including the identification of the
previously reported device by model number, catalog number or other
product identification, and the date of the baseline report for the
previously reported device;
(6) Basis for marketing, including 510(k) premarket notification
number or PMA number, if applicable, and whether the device is currently
the subject of an approved post-market study under section 522 of the
act;
(7) Date the device was initially marketed and, if applicable, the
date on which the manufacturer ceased marketing the device;
(8) Shelf life, if applicable, and expected life of the device;
(9) The number of devices manufactured and distributed in the last
12 months and, an estimate of the number of devices in current use; and
(10) Brief description of any methods used to estimate the number of
devices distributed and the method used to estimate the number of
devices in current use. If this information was provided in a previous
baseline report, in lieu of resubmitting the information, it may be
referenced by providing the date and product identification for the
previous baseline report.
Effective Date Note: At 61 FR 39869, July 31, 1996, in Sec. 803.55,
paragraphs (b)(9) and (10) were stayed indefinitely.
Sec. 803.56 Supplemental reports.
When a manufacturer obtains information required under this part
that was not provided because it was not known or was not available when
the initial report was submitted, the manufacturer shall submit to FDA
the supplemental information within 1 month following receipt of such
information. In supplemental reports, the manufacturer shall:
(a) Indicate on the form and the envelope, that the reporting form
being submitted is a supplemental report. If the report being
supplemented is an FDA Form 3500A report, the manufacturer must select,
in Item H-2, the appropriate code for the type of supplemental
information being submitted;
(b) Provide the appropriate identification numbers of the report
that will be updated with the supplemental information, e.g., original
manufacturer report number and user facility report number, if
applicable;
(c) For reports that cross reference previous reports, include only
the new, changed, or corrected information in the appropriate portion(s)
of the respective form(s).
Sec. 803.58 Foreign manufacturers.
(a) Every foreign manufacturer whose devices are distributed in the
United States shall designate a U.S. agent to be responsible for
reporting in accordance with Sec. 807.40 of this chapter. The U.S.
designated agent accepts responsibility for the duties that such
designation entails. Upon the effective date of this regulation, foreign
manufacturers shall inform FDA, by letter, of the name and address of
the U.S. agent designated under this section and Sec. 807.40 of this
chapter, and shall
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update this information as necessary. Such updated information shall be
submitted to FDA, within 5 days of a change in the designated agent
information.
(b) U.S.-designated agents of foreign manufacturers are required to:
(1) Report to FDA in accordance with Secs. 803.50, 803.52, 803.53,
803.55, and 803.56;
(2) Conduct, or obtain from the foreign manufacturer the necessary
information regarding, the investigation and evaluation of the event to
comport with the requirements of Sec. 803.50;
(3) Forward MDR complaints to the foreign manufacturer and maintain
documentation of this requirement;
(4) Maintain complaint files in accordance with Sec. 803.18; and
(5) Register, list, and submit premarket notifications in accordance
with part 807 of this chapter.
[60 FR 63597, Dec. 11, 1995, as amended at 66 FR 23157, May 8, 2001]
Effective Date Note: At 61 FR 38347, July 23, 1996, Sec. 803.58 was
stayed indefinitely.