[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR806]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 806_MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
Subpart A_General Provisions
Sec.
806.1 Scope.
806.2 Definitions.
Subpart B_Reports and Records
806.10 Reports of corrections and removals.
806.20 Records of corrections and removals not required to be reported.
806.30 FDA access to records.
806.40 Public availability of reports.
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Source: 62 FR 27191, May 19, 1997, unless otherwise noted.
Subpart A_General Provisions
Sec. 806.1 Scope.
(a) This part implements the provisions of section 519(f) of the
Federal Food, Drug, and Cosmetic Act (the act)
requiring device manufacturers and importers to report promptly to the
Food and Drug Administration (FDA) certain actions concerning device
corrections and removals, and to maintain records of all corrections and
removals regardless of whether such corrections and removals are
required to be reported to FDA.
(b) The following actions are exempt from the reporting requirements
of this part:
(1) Actions taken by device manufacturers or importers to improve
the performance or quality of a device but that do not reduce a risk to
health posed by the device or remedy a violation of the act caused by
the device.
(2) Market withdrawals as defined in Sec. 806.2(h).
(3) Routine servicing as defined in Sec. 806.2(k).
(4) Stock recoveries as defined in Sec. 806.2(l).
[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]
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Sec. 806.2 Definitions.
As used in this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency or FDA means the Food and Drug Administration.
(c) Consignee means any person or firm that has received, purchased,
or used a device subject to correction or removal.
(d) Correction means the repair, modification, adjustment,
relabeling, destruction, or inspection (including patient monitoring) of
a device without its physical removal from its point of use to some
other location.
(e) Correction or removal report number means the number that
uniquely identifies each report submitted.
(f) Importer means, for the purposes of this part, any person who
imports a device into the United States.
(g) Manufacturer means any person who manufactures, prepares,
propagates, compounds, assembles, or processes a device by chemical,
physical, biological, or other procedures. The term includes any person
who:
(1) Repackages or otherwise changes the container, wrapper, or
labeling of a device in furtherance of the distribution of the device
from the original place of manufacture to the person who makes final
delivery or sale to the ultimate user or consumer;
(2) Initiates specifications for devices that are manufactured by a
second party for subsequent distribution by the person initiating the
specifications; or
(3) Manufactures components or accessories which are devices that
are ready to be used and are intended to be commercially distributed and
are 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.
(h) Market withdrawal means a correction or removal of a distributed
device that involves a minor violation of the act that would not be
subject to legal action by FDA or that involves no violation of the act,
e.g., normal stock rotation practices.
(i) Removal means the physical removal of a device from its point of
use to some other location for repair, modification, adjustment,
relabeling, destruction, or inspection.
(j) Risk to health means
(1) A reasonable probability that use of, or exposure to, the
product will cause serious adverse health consequences or death; or
(2) That use of, or exposure to, the product may cause temporary or
medically reversible adverse health consequences, or an outcome where
the probability of serious adverse health consequences is remote.
(k) Routine servicing means any regularly scheduled maintenance of a
device, including the replacement of parts at the end of their normal
life expectancy, e.g., calibration, replacement of batteries, and
responses to normal wear and tear. Repairs of an unexpected nature,
replacement of parts earlier than their normal life expectancy, or
identical repairs or replacements of multiple units of a device are not
routine servicing.
(l) Stock recovery means the correction or removal of a device that
has not been marketed or that has not left the direct control of the
manufacturer, i.e., the device is located on the premises owned, or
under the control of, the manufacturer, and no portion of the lot,
model, code, or other relevant unit
involved in the corrective or removal action has been released for sale
or use.
[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998]
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Subpart B_Reports and Records
Sec. 806.10 Reports of corrections and removals.
(a) Each device manufacturer or importer shall submit a written
report to FDA of any correction or removal of a device initiated by such
manufacturer or importer if the correction or removal was initiated:
(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may
present a risk to health unless the information has already been
provided as set forth in paragraph (f) of this section or the corrective
or removal action is exempt from the reporting requirements under Sec.
806.1(b).
(b) The manufacturer or importer shall submit any report required by
paragraph (a) of this section within 10-working days of initiating such
correction or removal.
(c) The manufacturer or importer shall include the following
information in the report:
(1) The seven digit registration number of the entity responsible
for submission of the report of corrective or removal action (if
applicable), the month, day, and year that the report is made, and a
sequence number (i.e., 001 for the first report, 002 for the second
report, 003 etc.), and the report type designation ``C'' or ``R''. For
example, the complete number for the first correction report submitted
on June 1, 1997, will appear as follows for a firm with the registration
number 1234567: 1234567-6/1/97-001-C. The second correction report
number submitted by the same firm on July 1, 1997, would be 1234567-7/1/
97-002-C etc. For removals, the number will appear as follows: 1234567-
6/1/97-001-R and 1234567-7/1/97-002-R, etc. Firms that do not have a
seven digit registration number may use seven zeros followed by the
month, date, year, and sequence number (i.e. 0000000-6/1/97-001-C for
corrections and 0000000-7/1/97-001-R for removals). Reports received
without a seven digit registration number will be assigned a seven digit
central file number by the district office reviewing the reports.
(2) The name, address, and telephone number of the manufacturer or
importer, and the name, title, address, and telephone number of the
manufacturer or importer representative responsible for conducting the
device correction or removal.
(3) The brand name and the common name, classification name, or
usual name of the device and the intended use of the device.
(4) Marketing status of the device, i.e., any applicable premarket
notification number, premarket approval number, or indication that the
device is a preamendments device, and the device listing number. A
manufacturer or importer that does not have an FDA establishment
registration number shall indicate in the report whether it has ever
registered with FDA.
(5) The model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other identification
number.
(6) The manufacturer's name, address, telephone number, and contact
person if different from that of the person submitting the report.
(7) A description of the event(s) giving rise to the information
reported and the corrective or removal actions that have been, and are
expected to be taken.
(8) Any illness or injuries that have occurred with use of the
device. If applicable, include the medical device report numbers.
(9) The total number of devices manufactured or distributed subject
to the correction or removal and the number in the same batch, lot, or
equivalent unit of production subject to the correction or removal.
(10) The date of manufacture or distribution and the device's
expiration date or expected life.
(11) The names, addresses, and telephone numbers of all domestic and
foreign consignees of the device and the dates and number of devices
distributed to each such consignee.
(12) A copy of all communications regarding the correction or
removal and
the names and addresses of all recipients of the communications not
provided in accordance with paragraph (c)(11) of this section.
(13) If any required information is not immediately available, a
statement as to why it is not available and when it will be submitted.
(d) If, after submitting a report under this part, a manufacturer or
importer determines that the same correction or removal should be
extended to additional lots or batches of the same device, the
manufacturer or importer shall within 10-working days of initiating the
extension of the correction or removal, amend the report by submitting
an amendment citing the original report number assigned according to
paragraph (c)(1) of this section, all of the information required by
paragraph (c)(2), and any information required by paragraphs (c)(3)
through (c)(12) of this section that is different from the information
submitted in the original report. The manufacturer or importer shall
also provide a statement in accordance with paragraph (c)(13) of this
section for any required information that is not readily available.
(e) A report submitted by a manufacturer or importer under this
section (and any release by FDA of that report or information) does not
necessarily reflect a conclusion by the manufacturer, importer, or FDA
that the report or information constitutes an admission that the device
caused or contributed to a death or serious injury. A manufacturer or
importer need not admit, and may deny, that the report or information
submitted under this section constitutes an admission that the device
caused or contributed to a death or serious injury.
(f) No report of correction or removal is required under this part,
if a report of the correction or removal is required and has been
submitted under parts 803 or 1004 of this chapter.
[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 69
FR 11311, Mar. 10, 2004]
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Sec. 806.20 Records of corrections and removals not required to be
reported.
(a) Each device manufacturer or importer who initiates a correction
or removal of a device that is not required to be reported to FDA under
Sec. 806.10 shall keep a record of such correction or removal.
(b) Records of corrections and removals not required to be reported
to FDA under Sec. 806.10 shall contain the following information:
(1) The brand name, common or usual name, classification, name and
product code if known, and the intended use of the device.
(2) The model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other identification
number.
(3) A description of the event(s) giving rise to the information
reported and the corrective or removal action that has been, and is
expected to be taken.
(4) Justification for not reporting the correction or removal action
to FDA, which shall contain conclusions and any followups, and be
reviewed and evaluated by a designated person.
(5) A copy of all communications regarding the correction or
removal.
(c) The manufacturer or importer shall retain records required under
this section for a period of 2 years beyond the expected life of the
device, even if the manufacturer or importer has ceased to manufacture
or import the device. Records required to be maintained under paragraph
(b) of this section must be transferred to the new manufacturer or
importer of the device and maintained for the required period of time.
[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998]
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Sec. 806.30 FDA access to records.
Each device manufacturer or importer required under this part to
maintain records and every person who is in charge or custody of such
records shall, upon request of an officer or employee designated by FDA
and under section 704(e) of the act, permit such officer or employee at
all reasonable times to have access to, and to copy and verify, such
records and reports.
[63 FR 42233, Aug. 7, 1998]
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Sec. 806.40 Public availability of reports.
(a) Any 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;
and
(2) Any personnel, medical, or similar information, including the
serial numbers of implanted devices, which would constitute a clearly
unwarranted invasion of personal privacy under Sec. 20.63 of this
chapter or 5 U.S.C. 552(b)(6); provided, that except for the information
under Sec. 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will
disclose to a patient who requests a report all the information in the
report concerning that patient.
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