[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: 21CFR807]
[Page 59-74]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 807_ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS
AND INITIAL IMPORTERS OF DEVICES
Subpart A_General Provisions
Sec.
807.3 Definitions.
Subpart B_Procedures for Device Establishments
807.20 Who must register and submit a device list?
807.21 Times for establishment registration and device listing.
807.22 How and where to register establishments and list devices.
807.25 Information required or requested for establishment registration
and device listing.
807.26 Amendments to establishment registration.
807.30 Updating device listing information.
807.31 Additional listing information.
807.35 Notification of registrant.
807.37 Inspection of establishment registration and device listings.
807.39 Misbranding by reference to establishment registration or to
registration number.
Subpart C_Registration Procedures for Foreign Device Establishments
807.40 Establishment registration and device listing for foreign
establishments importing or offering for import devices into
the United States.
Subpart D_Exemptions
807.65 Exemptions for device establishments.
Subpart E_Premarket Notification Procedures
807.81 When a premarket notification submission is required.
807.85 Exemption from premarket notification.
807.87 Information required in a premarket notification submission.
807.90 Format of a premarket notification submission.
807.92 Content and format of a 510(k) summary.
807.93 Content and format of a 510(k) statement.
807.94 Format of class III certification.
807.95 Confidentiality of information.
807.97 Misbranding by reference to premarket notification.
807.100 FDA action on a premarket notification.
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 807.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Commercial distribution means any distribution of a device
intended for human use which is held or offered for sale but does not
include the following:
(1) Internal or interplant transfer of a device between
establishments within the same parent, subsidiary, and/or affiliate
company;
(2) Any distribution of a device intended for human use which has in
effect an approved exemption for investigational use under section
520(g) of the act and part 812 of this chapter;
(3) Any distribution of a device, before the effective date of part
812 of this chapter, that was not introduced or delivered for
introduction into interstate commerce for commercial distribution before
May 28, 1976, and that is classified into class III under section 513(f)
of the act: Provided, That the device is intended solely for
investigational use, and under section 501(f)(2)(A) of the act the
device is not
required to have an approved premarket approval application as provided
in section 515 of the act; or
(4) For foreign establishments, the distribution of any device that
is neither imported nor offered for import into the United States.
(c) Establishment means a place of business under one management at
one general physical location at which a device is manufactured,
assembled, or otherwise processed.
(d) Manufacture, preparation, propagation, compounding, assembly, or
processing of a device means the making by chemical, physical,
biological, or other procedures of any article that meets the definition
of device in section 201(h) of the act. These terms include the
following activities:
(1) Repackaging or otherwise changing the container, wrapper, or
labeling of any device package 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 consumer;
(2) Initial importation of devices manufactured in foreign
establishments; or
(3) Initiation of specifications for devices that are manufactured
by a second party for subsequent commercial distribution by the person
initiating specifications.
(e) Official correspondent means the person designated by the owner
or operator of an establishment as responsible for the following:
(1) The annual registration of the establishment;
(2) Contact with the Food and Drug Administration for device
listing;
(3) Maintenance and submission of a current list of officers and
directors to the Food and Drug Administration upon the request of the
Commissioner;
(4) The receipt of pertinent correspondence from the Food and Drug
Administration directed to and involving the owner or operator and/or
any of the firm's establishments; and
(5) The annual certification of medical device reports required by
Sec. 804.30 of this chapter or forwarding the certification form to the
person designated by the firm as responsible for the certification.
(f) Owner or operator means the corporation, subsidiary, affiliated
company, partnership, or proprietor directly responsible for the
activities of the registering establishment.
(g) Initial importer means any importer who furthers the marketing
of a device from a foreign manufacturer to the person who makes the
final delivery or sale of the device to the ultimate consumer or user,
but does not repackage, or otherwise change the container, wrapper, or
labeling of the device or device package.
(h) Any term defined in section 201 of the act shall have that
meaning.
(i) Restricted device means a device for which the Commissioner, by
regulation under Sec. 801.109 of this chapter or otherwise under
section 520(e) of the act, has restricted sale, distribution, or use
only upon the written or oral authorization of a practitioner licensed
by law to administer or use the device or upon such other conditions as
the Commissioner may prescribe.
(j) Classification name means the term used by the Food and Drug
Administration and its classification panels to describe a device or
class of devices for purposes of classifying devices under section 513
of the act.
(k) Representative sampling of advertisements means typical
advertising material that gives the promotional claims made for the
device.
(l) Representative sampling of any other labeling means typical
labeling material (excluding labels and package inserts) that gives the
promotional claims made for the device.
(m) Material change includes any change or modification in the
labeling or advertisements that affects the identity or safety and
effectiveness of the device. These changes may include, but are not
limited to, changes in the common or usual or proprietary name, declared
ingredients or components, intended use, contraindications, warnings, or
instructions for use. Changes that are not material may include graphic
layouts, grammar, or correction of typographical errors which do not
change the content of the labeling, changes in lot number, and, for
devices where the biological activity or known
composition differs with each lot produced, the labeling containing the
actual values for each lot.
(n) 510(k) summary (summary of any information respecting safety and
effectiveness) means a summary, submitted under section 513(i) of the
act, of the safety and effectiveness information contained in a
premarket notification submission upon which a determination of
substantial equivalence can be based. Safety and effectiveness
information refers to safety and effectiveness data and information
supporting a finding of substantial equivalence, including all adverse
safety and effectiveness information.
(o) 510(k) statement means a statement, made under section 513(i) of
the act, asserting that all information in a premarket notification
submission regarding safety and effectiveness will be made available
within 30 days of request by any person if the device described in the
premarket notification submission is determined to be substantially
equivalent. The information to be made available will be a duplicate of
the premarket notification submission, including any adverse safety and
effectiveness information, but excluding all patient identifiers, and
trade secret or confidential commercial information, as defined in Sec.
20.61 of this chapter.
(p) Class III certification means a certification that the submitter
of the 510(k) has conducted a reasonable search of all known information
about the class III device and other similar, legally marketed devices.
(q) Class III summary means a summary of the types of safety and
effectiveness problems associated with the type of device being compared
and a citation to the information upon which the summary is based. The
summary must be comprehensive and describe the problems to which the
type of device is susceptible and the causes of such problems.
(r) United States agent means a person residing or maintaining a
place of business in the United States whom a foreign establishment
designates as its agent. This definition excludes mailboxes, answering
machines or services, or other places where an individual acting as the
foreign establishment's agent is not physically present.
(s) Wholesale distributor means any person (other than the
manufacturer or the initial importer) who distributes a device from the
original place of manufacture to the person who makes the final delivery
or sale of the device to the ultimate consumer or user.
[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978;
57 FR 18066, Apr. 28, 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295,
Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998;
66 FR 59159, Nov. 27, 2001]
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Subpart B_Procedures for Device Establishments
Sec. 807.20 Who must register and submit a device list?
(a) An owner or operator of an establishment not exempt under
section 510(g) of the act or subpart D of this part who is engaged in
the manufacture, preparation, propagation, compounding, assembly, or
processing of a device intended for human use shall register and submit
listing information for those devices in commercial distribution, except
that registration and listing information may be submitted by the
parent, subsidiary, or affiliate company for all the domestic or foreign
establishments under the control of one of these organizations when
operations are conducted at more than one establishment and there exists
joint ownership and control among all the establishments. The term
``device'' includes all in vitro diagnostic products and in vitro
diagnostic biological products not subject to licensing under section
351 of the Public Health Service Act. An owner or operator of an
establishment located in any State as defined in section 201(a)(1) of
the act shall register its name, places of business, and all
establishments and list the devices whether or not the output of the
establishments or any particular device so listed enters interstate
commerce. The registration and listing requirements shall pertain to any
person who:
(1) Initiates or develops specifications for a device that is to be
manufactured by a second party for commercial distribution by the person
initiating specifications;
(2) Manufactures for commercial distribution a device either for
itself or for another person. However, a person who only manufactures
devices according to another person's specifications, for commercial
distribution by the person initiating specifications, is not required to
list those devices.
(3) Repackages or relabels a device;
(4) Acts as an initial importer; or
(5) Manufactures components or accessories which are ready to be
used for any intended health-related purpose and are packaged or labeled
for commercial distribution for such health-related purpose, e.g., blood
filters, hemodialysis tubing, or devices which of necessity must be
further processed by a licensed practitioner or other qualified person
to meet the needs of a particular patient, e.g., a manufacturer of
ophthalmic lens blanks.
(b) No registration or listing fee is required. Registration or
listing does not constitute an admission or agreement or determination
that a product is a device within the meaning of section 201(h) of the
act.
(c) Registration and listing requirements shall not pertain to any
person who:
(1) Manufacturers devices for another party who both initiated the
specifications and commercially distributes the device;
(2) Sterilizes devices on a contract basis for other registered
facilities who commercially distribute the devices.
(3) Acts as a wholesale distributor, as defined in Sec. 807.3(s),
and who does not manufacture, repackage, process, or relabel a device.
(d) Owners and operators of establishments or persons engaged in the
recovery, screening, testing, processing, storage, or distribution of
human cells, tissues, and cellular and tissue-based products, as defined
in Sec. 1271.3(d) of this chapter, that are regulated under the Federal
Food, Drug, and Cosmetic Act must register and list those human cells,
tissues, and cellular and tissue-based products with the Center for
Biologics Evaluation and Research on Form FDA 3356 following the
procedures set out in subpart B of part 1271 of this chapter, instead of
the procedures for registration and listing contained in this part,
except that the additional listing information requirements of Sec.
807.31 remain applicable.
[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978;
58 FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11, 1995; 63 FR 51826,
Sept. 29, 1998; 66 FR 5466, Jan. 19, 2001; 66 FR 59160, Nov. 27, 2001]
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Sec. 807.21 Times for establishment registration and device listing.
(a) An owner or operator of an establishment who has not previously
entered into an operation defined in Sec. 807.20 shall register within
30 days after entering into such an operation and submit device listing
information at that time. An owner or operator of an establishment shall
update its registration information annually within 30 days after
receiving registration forms from FDA. FDA will mail form FDA-2891a to
the owners or operators of registered establishments according to a
schedule based on the first letter of the name of the owner or operator.
The schedule is as follows:
------------------------------------------------------------------------
First letter of owner or operator name Date FDA will mail forms
------------------------------------------------------------------------
A, B, C, D, E............................. March.
F, G, H, I, J, K, L, M.................... June.
N, O, P, Q, R............................. August.
S, T, U, V, W, X, Y, Z.................... November.
------------------------------------------------------------------------
(b) Owners or operators of all registered establishments shall
update their device listing information every June and December or, at
their discretion, at the time the change occurs.
[58 FR 46522, Sept. 1, 1993]
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Sec. 807.22 How and where to register establishments and list devices.
(a) The first registration of a device establishment shall be on
Form FDA-2891 (Initial Registration of Device Establishment). Forms are
available upon request from the Office of Compliance, Center for Devices
and Radiological Health (HFZ-308), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-4015, or from Food and Drug
Administration district offices. Subsequent annual registration shall be
accomplished on Form FDA-2891a (Annual Registration of Device
Establishment), which will be furnished by FDA to establishments whose
registration for that year was validated under Sec. 807.35(a). The
forms
will be mailed to the owner or operators of all establishments via the
official correspondent in accordance with the schedule as described in
Sec. 807.21(a). The completed form shall be mailed to the address
designated in this paragraph 30 days after receipt from FDA.
(b) The initial listing of devices and subsequent June and December
updatings shall be on form FDA-2892 (Medical Device Listing). Forms are
obtainable upon request as described in paragraph (a) of this section. A
separate form FDA-2892 shall be submitted for each device or device
class listed with the Food and Drug Administration. Devices having
variations in physical characteristics such as size, package, shape,
color, or composition should be considered to be one device: Provided,
The variation does not change the function or intended use of the
device. In lieu of form FDA-2892, tapes for computer input or hard copy
computer output may by submitted if equivalent in all elements of
information as specified in form FDA-2892. All formats proposed for use
in lieu of form FDA-2892 require initial review and approval by the Food
and Drug Administration.''
(c) The listing obligations of the initial importer are satisfied as
follows:
(1) The initial importer is not required to submit a form FDA-2892
for those devices for which such initial importer did not initiate or
develop the specifications for the device or repackage or relabel the
device. However, the initial importer shall submit, for each device, the
name and address of the manufacturer. Initial importers shall also be
prepared to submit, when requested by FDA, the proprietary name, if any,
and the common or usual name of each device for which they are the
initial importers; and
(2) The initial importer shall update the information required by
paragraphs (c)(1) of this section at the intervals specified in Sec.
807.30.
[43 FR 37997, Aug. 25, 1978, as amended at 58 FR 46522, Sept. 1, 1993;
60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998; 69 FR 11311,
Mar. 10, 2004; 69 FR 18473, Apr. 8, 2004; 69 FR 25489, May 7, 2004]
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Sec. 807.25 Information required or requested for establishment
registration and device listing.
(a) Form FDA-2891 and Form FDA-2891(a) are the approved forms for
initially providing the information required by the act and for
providing annual registration, respectively. The required information
includes the name and street address of the device establishment,
including post office code, all trade names used by the establishment,
and the business trading name of the owner or operator of such
establishment.
(b) The owner or operator shall identify the device activities of
the establishment such as manufacturing, repackaging, or distributing
devices.
(c) Each owner or operator is required to maintain a listing of all
officers, directors, and partners for each establishment he registers
and to furnish this information to the Food and Drug Administration upon
request.
(d) Each owner or operator shall provide the name of an official
correspondent who will serve as a point of contact between the Food and
Drug Administration and the establishment for matters relating to the
registration of device establishments and the listing of device
products. All future correspondence relating to registration, including
requests for the names of partners, officers, and directors, will be
directed to this official correspondent. In the event no person is
designated by the owner or operator, the owner or operator of the
establishment will be the official correspondent.
(e) The designation of an official correspondent does not in any
manner affect the liability of the owner or operator of the
establishment or any other individual under section 301(p) or any other
provision of the act.
(f) Form FD-2892 is the approved form for providing the device
listing information required by the act. This required information
includes the following:
(1) The identification by classification name and number,
proprietary name, and common or usual name of each device being
manufactured, prepared, propagated, compounded, or processed for
commercial distribution that has not been included in any list
of devices previously submitted on form FDA-2892.
(2) The Code of Federal Regulations citation for any applicable
standard for the device under section 514 of the act or section 358 of
the Public Health Service Act.
(3) The assigned Food and Drug Administration number of the approved
application for each device listed that is subject to section 505 or 515
of the act.
(4) The name, registration number, and establishment type of every
domestic or foreign device establishment under joint ownership and
control of the owner or operator at which the device is manufactured,
repackaged, or relabeled.
(5) Whether the device, as labeled, is intended for distribution to
and use by the general public.
(6) Other general information requested on form FDA-2892, i.e.,
(i) If the submission refers to a previously listed device, as in
the case of an update, the document number from the initial listing
document for the device,
(ii) The reason for submission,
(iii) The date on which the reason for submission occurred,
(iv) The date that the form FDA-2892 was completed,
(v) The owner's or operator's name and identification number.
(7) Labeling or other descriptive information (e.g., specification
sheets or catalogs) adequate to describe the intended use of a device
when the owner or operator is unable to find an appropriate FDA
classification name for the device.
[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37998, Aug. 25, 1978;
58 FR 46523, Sept. 1, 1993; 64 FR 404, Jan. 5, 1999; 66 FR 59160, Nov.
27, 2001; 69 FR 11312, Mar. 10, 2004]
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Sec. 807.26 Amendments to establishment registration.
Changes in individual ownership, corporate or partnership structure,
or location of an operation defined in Sec. 807.3(c) shall be submitted
on Form FDA-2891(a) at the time of annual registration, or by letter if
the changes occur at other times. This information shall be submitted
within 30 days of such changes. Changes in the names of officers and/or
directors of the corporation(s) shall be filed with the establishment's
official correspondent and shall be provided to the Food and Drug
Administration upon receipt of a written request for this information.
[69 FR 11312, Mar. 10, 2004]
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Sec. 807.30 Updating device listing information.
(a) Form FDA-2892 shall be used to update device listing
information. The preprinted original document number of each form FDA-
2892 on which the device was initially listed shall appear on the form
subsequently used to update the listing information for the device and
on any correspondence related to the device.
(b) An owner or operator shall update the device listing information
during each June and December or, at its discretion, at the time the
change occurs. Conditions that require updating and information to be
submitted for each of these updates are as follows:
(1) If an owner or operator introduces into commercial distribution
a device identified with a classification name not currently listed by
the owner or operator, then the owner or operator must submit form FDA-
2892 containing all the information required by Sec. 807.25(f).
(2) If an owner or operator discontinues commercial distribution of
all devices in the same device class, i.e., with the same classification
name, the owner or operator must submit form FDA-2892 containing the
original document number of the form FDA-2892 on which the device class
was initially listed, the reason for submission, the date of
discontinuance, the owner or operator's name and identification number,
the classification name and number, the proprietary name, and the common
or usual name of the discontinued device.
(3) If commercial distribution of a discontinued device identified
on a form FDA-2892 filed under paragraph (b)(2) of this section is
resumed, the owner or operator must submit on form FDA-2892 a notice of
resumption containing: the original document number of the form
initially used to list that device class, the reason for submission,
date of resumption, and all other information required by Sec.
807.25(f).
(4) If one or more classification names for a previously listed
device with multiple classification names has been added or deleted, the
owner or operator must supply the original document number from the form
FDA-2892 on which the device was initially listed and a supplemental
sheet identifying the names of any new or deleted classification names.
(5) Other changes to information on form FDA-2892 will be updated as
follows:
(i) Whenever a change occurs only in the owner or operator name or
number, e.g., whenever one company's device line is purchased by another
owner or operator, it will not be necessary to supply a separate form
FDA-2892 for each device. In such cases, the new owner or operator must
follow the procedures in Sec. 807.26 and submit a letter informing the
Food and Drug Administration of the original document number from form
FDA-2892 on which each device was initially listed for those devices
affected by the change in ownership.
(ii) The owner or operator must also submit update information
whenever establishment registration numbers, establishment names, and/or
activities are added to or deleted from form FDA 2892. The owner or
operator must supply the original document number from the form FDA-2892
on which the device was initially listed, the reason for submission, and
all other information required by Sec. 807.25(f).
(6) Updating is not required if the above information has not
changed since the previously submitted list. Also, updating is not
required if changes occur in proprietary names, in common or usual
names, or to supplemental lists of unclassified components or
accessories.
[69 FR 11312, Mar. 10, 2004]
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Sec. 807.31 Additional listing information.
(a) Each owner or operator shall maintain a historical file
containing the labeling and advertisements in use on the date of initial
listing, and in use after October 10, 1978, but before the date of
initial listing, as follows:
(1) For each device subject to section 514 or 515 of the act that is
not a restricted device, a copy of all labeling for the device;
(2) For each restricted device, a copy of all labeling and
advertisements for the device;
(3) For each device that is neither restricted nor subject to
section 514 or 515 of the act, a copy of all labels, package inserts,
and a representative sampling of any other labeling.
(b) In addition to the requirements set forth in paragraph (a) of
this section, each owner or operator shall maintain in the historical
file any labeling or advertisements in which a material change has been
made anytime after initial listing.
(c) Each owner or operator may discard labeling and advertisements
from the historical file 3 years after the date of the last shipment of
a discontinued device by an owner or operator.
(d) Location of the file:
(1) Currently existing systems for maintenance of labeling and
advertising may be used for the purpose of maintaining the historical
file as long as the information included in the systems fulfills the
requirements of this section, but only if the labeling and
advertisements are retrievable in a timely manner.
(2) The contents of the historical file may be physically located in
more than one place in the establishment or in more than one
establishment provided there exists joint ownership and control among
all the establishments maintaining the historical file. If no joint
ownership and control exists, the registered establishment must provide
the Food and Drug Administration with a letter authorizing the
establishment outside its control to maintain the historical file.
(3) A copy of the certification and disclosure statements as
required by part 54 of this chapter shall be retained and physically
located at the establishment maintaining the historical file.
(e) Each owner or operator shall be prepared to submit to the Food
and Drug Administration, only upon specific request, the following
information:
(1) For a device subject to section 514 or 515 of the act that is
not a restricted device, a copy of all labeling for the device.
(2) For a device that is a restricted device, a copy of all labeling
for the device, a representative sampling of advertisements for the
device, and for good cause, a copy of all advertisements for a
particular device. A request for all advertisements will, where
feasible, be accompanied by an explanation of the basis for such
request.
(3) For a device that is neither a restricted device, nor subject to
section 514 of 515 of the act, the label and package insert for the
device and a representative sampling of any other labeling for the
device.
(4) For a particular device, a statement of the basis upon which the
registrant has determined that the device is not subject to section 514
or 515 of the act.
(5) For a particular device, a statement of the basis upon which the
registrant has determined the device is not a restricted device.
(6) For a particular device, a statement of the basis for
determining that the product is a device rather than a drug.
(7) For a device that the owner or operator has manufactured for
distribution under a label other than its own, the names of all
distributors for whom it has been manufactured.
[43 FR 37999, Aug. 25, 1978, as amended at 51 FR 33033, Sept. 18, 1986;
63 FR 5253, Feb. 2, 1998]
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Sec. 807.35 Notification of registrant.
(a) The Commissioner will provide to the official correspondent, at
the address listed on the form, a validated copy of Form FDA-2891 or
Form FDA-2891(a) (whichever is applicable) as evidence of registration.
A permanent registration number will be assigned to each device
establishment registered in accordance with these regulations.
(b) Owners and operators of device establishments who also
manufacture or process blood or drug products at the same establishment
shall also register with the Center for Biologics Evaluation and
Research and Center for Drug Evaluation and Research, as appropriate.
Blood products shall be listed with the Center for Biologics Evaluation
and Research, Food and Drug Administration, pursuant to part 607 of this
chapter; drug products shall be listed with the Center for Drug
Evaluation and Research, Food and Drug Administration, pursuant to part
207 of this chapter.
(c) Although establishment registration and device listing are
required to engage in the device activities described in Sec. 807.20,
validation of registration and the assignment of a device listing number
in itself does not establish that the holder of the registration is
legally qualified to deal in such devices and does not represent a
determination by the Food and Drug Administration as to the status of
any device.
[69 FR 11312, Mar. 10, 2004]
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Sec. 807.37 Inspection of establishment registration and device
listings.
(a) A copy of the forms FDA-2891 and FDA-2891a filed by the
registrant will be available for inspection in accordance with section
510(f) of the act, at the Center for Devices and Radiological Health
(HFZ-308), Food and Drug Administration, Department of Health and Human
Services, 9200 Corporate Blvd., Rockville, MD 20850-4015. In addition,
there will be available for inspection at each of the Food and Drug
Administration district offices the same information for firms within
the geographical area of such district office. Upon request,
verification of registration number or location of a registered
establishment will be provided.
(b)(1) The following information filed under the device listing
requirements will be available for public disclosure:
(i) Each form FDA-2892 submitted;
(ii) All labels submitted;
(iii) All labeling submitted;
(iv) All advertisements submitted;
(v) All data or information that has already become a matter of
public knowledge.
(2) Requests for device listing information identified in paragraph
(b)(1) of this section should be directed to the Center for Devices and
Radiological Health (HFZ-308), Food and Drug Administration, Department
of Health and Human Services, 9200 Corporate Blvd., Rockville, MD 20850-
4015.
(3) Requests for device listing information not identified in
paragraph (b)(1) of this section shall be submitted and handled in
accordance with part 20 of this chapter.
[69 FR 11313, Mar. 10, 2004]
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Sec. 807.39 Misbranding by reference to establishment registration or
to registration number.
Registration of a device establishment or assignment of a
registration number does not in any way denote approval of the
establishment or its products. Any representation that creates an
impression of official approval because of registration or possession of
a registration number is misleading and constitutes misbranding.
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Subpart C_Registration Procedures for Foreign Device Establishments
Sec. 807.40 Establishment registration and device listing for foreign
establishments importing or offering for import devices into
the United States.
(a) Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of a
device that is imported or offered for import into the United States
shall register and list such devices in conformance with the
requirements in subpart B of this part unless the device enters a
foreign trade zone and is re-exported from that foreign trade zone
without having entered U. S. commerce. The official correspondent for
the foreign establishment shall facilitate communication between the
foreign establishment's management and representatives of the Food and
Drug Administration for matters relating to the registration of device
establishments and the listing of device products.
(b) Each foreign establishment required to register under paragraph
(a) of this section shall submit the name, address, and phone number of
its United States agent as part of its initial and updated registration
information in accordance with subpart B of this part. Each foreign
establishment shall designate only one United States agent and may
designate the United States agent to act as its official correspondent.
(1) The United States agent shall reside or maintain a place of
business in the United States.
(2) Upon request from FDA, the United States agent shall assist FDA
in communications with the foreign establishment, respond to questions
concerning the foreign establishment's products that are imported or
offered for import into the United States, and assist FDA in scheduling
inspections of the foreign establishment. If the agency is unable to
contact the foreign establishment directly or expeditiously, FDA may
provide information or documents to the United States agent, and such an
action shall be considered to be equivalent to providing the same
information or documents to the foreign establishment.
(3) The foreign establishment or the United States agent shall
report changes in the United States agent's name, address, or phone
number to FDA within 10-business days of the change.
(c) No device may be imported or offered for import into the United
States unless it is the subject of a device listing as required under
subpart B of this part and is manufactured, prepared, propagated,
compounded, or processed at a registered foreign establishment; however,
this restriction does not apply to devices imported or offered for
import under the investigational use provisions of part 812 of this
chapter or to a component, part, or accessory of a device or other
article of a device imported under section 801(d)(3) of the act. The
establishment registration and device listing information shall be in
the English language.
[66 FR 59160, Nov. 27, 2001]
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Subpart D_Exemptions
Sec. 807.65 Exemptions for device establishments.
The following classes of persons are exempt from registration in
accordance with Sec. 807.20 under the provisions of section 510(g)(1),
(g)(2), and (g)(3) of the act, or because the Commissioner of Food and
Drugs has found, under section 510(g)(5) of the act, that such
registration is not necessary for the
protection of the public health. The exemptions in paragraphs (d), (e),
(f), and (i) of this section are limited to those classes of persons
located in any State as defined in section 201(a)(1) of the act.
(a) A manufacturer of raw materials or components to be used in the
manufacture or assembly of a device who would otherwise not be required
to register under the provisions of this part.
(b) A manufacturer of devices to be used solely for veterinary
purposes.
(c) A manufacturer of general purpose articles such as chemical
reagents or laboratory equipment whose uses are generally known by
persons trained in their use and which are not labeled or promoted for
medical uses.
(d) Licensed practitioners, including physicians, dentists, and
optometrists, who manufacture or otherwise alter devices solely for use
in their practice.
(e) Pharmacies, surgical supply outlets, or other similar retail
establishments making final delivery or sale to the ultimate user. This
exemption also applies to a pharmacy or other similar retail
establishment that purchases a device for subsequent distribution under
its own name, e.g., a properly labeled health aid such as an elastic
bandage or crutch, indicating ``distributed by'' or ``manufactured for''
followed by the name of the pharmacy.
(f) Persons who manufacture, prepare, propagate, compound, or
process devices solely for use in research, teaching, or analysis and do
not introduce such devices into commercial distribution.
(g) [Reserved]
(h) Carriers by reason of their receipt, carriage, holding or
delivery of devices in the usual course of business as carriers.
(i) Persons who dispense devices to the ultimate consumer or whose
major responsibility is to render a service necessary to provide the
consumer (i.e., patient, physician, layman, etc.) with a device or the
benefits to be derived from the use of a device; for example, a hearing
aid dispenser, optician, clinical laboratory, assembler of diagnostic x-
ray systems, and personnel from a hospital, clinic, dental laboratory,
orthotic or prosthetic retail facility, whose primary responsibility to
the ultimate consumer is to dispense or provide a service through the
use of a previously manufactured device.
[42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993;
61 FR 44615, Aug. 28, 1996; 65 FR 17136, Mar. 31, 2000; 66 FR 59160,
Nov. 27, 2001]
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Subpart E_Premarket Notification Procedures
Sec. 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person
who is required to register his establishment pursuant to Sec. 807.20
must submit a premarket notification submission to the Food and Drug
Administration at least 90 days before he proposes to begin the
introduction or delivery for introduction into interstate commerce for
commercial distribution of a device intended for human use which meets
any of the following criteria:
(1) The device is being introduced into commercial distribution for
the first time; that is, the device is not of the same type as, or is
not substantially equivalent to, (i) a device in commercial distribution
before May 28, 1976, or (ii) a device introduced for commercial
distribution after May 28, 1976, that has subsequently been reclassified
into class I or II.
(2) The device is being introduced into commercial distribution for
the first time by a person required to register, whether or not the
device meets the criteria in paragraph (a)(1) of this section.
(3) The device is one that the person currently has in commercial
distribution or is reintroducing into commercial distribution, but that
is about to be significantly changed or modified in design, components,
method of manufacture, or intended use. The following constitute
significant changes or modifications that require a premarket
notification:
(i) A change or modification in the device that could significantly
affect the safety or effectiveness of the device, e.g., a significant
change or modification in design, material, chemical composition, energy
source, or manufacturing process.
(ii) A major change or modification in the intended use of the
device.
(b) A premarket notification under this subpart is not required for
a device for which a premarket approval application under section 515 of
the act, or for which a petition to reclassify under section 513(f)(2)
of the act, is pending before the Food and Drug Administration.
(c) In addition to complying with the requirements of this part,
owners or operators of device establishments that manufacture radiation-
emitting electronic products, as defined in Sec. 1000.3 of this
chapter, shall comply with the reporting requirements of part 1002 of
this chapter.
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Sec. 807.85 Exemption from premarket notification.
(a) A device is exempt from the premarket notification requirements
of this subpart if the device intended for introduction into commercial
distribution is not generally available in finished form for purchase
and is not offered through labeling or advertising by the manufacturer,
importer, or distributor thereof for commercial distribution, and the
device meets one of the following conditions:
(1) It is intended for use by a patient named in the order of the
physician or dentist (or other specially qualified person); or
(2) It is intended solely for use by a physician or dentist (or
other specially qualified person) and is not generally available to, or
generally used by, other physicians or dentists (or other specially
qualified persons).
(b) A distributor who places a device into commercial distribution
for the first time under his own name and a repackager who places his
own name on a device and does not change any other labeling or otherwise
affect the device shall be exempted from the premarket notification
requirements of this subpart if:
(1) The device was in commercial distribution before May 28, 1976;
or
(2) A premarket notification submission was filed by another person.
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Sec. 807.87 Information required in a premarket notification
submission.
Each premarket notification submission shall contain the following
information:
(a) The device name, including both the trade or proprietary name
and the common or usual name or classification name of the device.
(b) The establishment registration number, if applicable, of the
owner or operator submitting the premarket notification submission.
(c) The class in which the device has been put under section 513 of
the act and, if known, its appropriate panel; or, if the owner or
operator determines that the device has not been classified under such
section, a statement of that determination and the basis for the
person's determination that the device is not so classified.
(d) Action taken by the person required to register to comply with
the requirements of the act under section 514 for performance standards.
(e) Proposed labels, labeling, and advertisements sufficient to
describe the device, its intended use, and the directions for its use.
Where applicable, photographs or engineering drawings should be
supplied.
(f) A statement indicating the device is similar to and/or different
from other products of comparable type in commercial distribution,
accompanied by data to support the statement. This information may
include an identification of similar products, materials, design
considerations, energy expected to be used or delivered by the device,
and a description of the operational principles of the device.
(g) Where a person required to register intends to introduce into
commercial distribution a device that has undergone a significant change
or modification that could significantly affect the safety or
effectiveness of the device, or the device is to be marketed for a new
or different indication for use, the premarket notification submission
must include appropriate supporting data to show that the manufacturer
has considered what consequences and effects the change or modification
or new use might have on the safety and effectiveness of the device.
(h) A 510(k) summary as described in Sec. 807.92 or a 510(k)
statement as described in Sec. 807.93.
(i) A financial certification or disclosure statement or both, as
required by part 54 of this chapter.
(j) For submissions claiming substantial equivalence to a device
which has been classified into class III under section 513(b) of the
act:
(1) Which was introduced or delivered for introduction into
interstate commerce for commercial distribution before December 1, 1990;
and
(2) For which no final regulation requiring premarket approval has
been issued under section 515(b) of the act, a summary of the types of
safety and effectiveness problems associated with the type of devices
being compared and a citation to the information upon which the summary
is based (class III summary). The 510(k) submitter shall also certify
that a reasonable search of all information known or otherwise available
about the class III device and other similar legally marketed devices
has been conducted (class III certification), as described in Sec.
807.94. This information does not refer to information that already has
been submitted to the Food and Drug Administration (FDA) under section
519 of the act. FDA may require the submission of the adverse safety and
effectiveness data described in the class III summary or citation.
(k) A statement that the submitter believes, to the best of his or
her knowledge, that all data and information submitted in the premarket
notification are truthful and accurate and that no material fact has
been omitted.
(l) Any additional information regarding the device requested by the
Commissioner that is necessary for the Commissioner to make a finding as
to whether or not the device is substantially equivalent to a device in
commercial distribution. A request for additional information will
advise the owner or operator that there is insufficient information
contained in the original premarket notification submission for the
Commissioner to make this determination and that the owner or operator
may either submit the requested data or a new premarket notification
containing the requested information at least 90 days before the owner
or operator intends to market the device, or submit a premarket approval
application in accordance with section 515 of the act. If the additional
information is not submitted within 30 days following the date of the
request, the Commissioner will consider the premarket notification to be
withdrawn.
(Information collection requirements in this section were approved by
the Office of Management and Budget (OMB) and assigned OMB control
number 0910-0281)
[42 FR 42526, Aug 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992; 59
FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998]
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Sec. 807.90 Format of a premarket notification submission.
Each premarket notification submission pursuant to this part shall
be submitted in accordance with this section. Each submission shall:
(a)(1) For devices regulated by the Center for Devices and
Radiological Health, be addressed to the Food and Drug Administration,
Center for Devices and Radiological Health (HFZ-401), 9200 Corporate
Blvd., Rockville, MD 20850.
(2) For devices regulated by the Center for Biologics Evaluation and
Research, be addressed to the Document Control Center (HFM-99), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or for
devices regulated by the Center for Drug Evaluation and Research, be
addressed to the Central Document Room, Center for Drug Evaluation and
Research, Food and Drug Administration, 5901-B Ammendale Rd.,
Beltsville, MD 20705-1266. Information about devices regulated by the
Center for Biologics Evaluation and Research is available at http://
www.fda.gov/cber/dap/devlst.htm on the Internet.
(3) All inquiries regarding a premarket notification submission
should be in writing and sent to one of the addresses above.
(b) Be bound into a volume or volumes, where necessary.
(c) Be submitted in duplicate on standard size paper, including the
original and two copies of the cover letter.
(d) Be submitted separately for each product the manufacturer
intends to market.
(e) Designated ``510(k) Notification'' in the cover letter.
[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 55
FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000; 70 FR 14986, Mar.
24, 2005]
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Sec. 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an
understanding of the basis for a determination of substantial
equivalence. FDA will accept summaries as well as amendments thereto
until such time as FDA issues a determination of substantial
equivalence. All 510(k) summaries shall contain the following
information:
(1) The submitter's name, address, telephone number, a contact
person, and the date the summary was prepared;
(2) The name of the device, including the trade or proprietary name
if applicable, the common or usual name, and the classification name, if
known;
(3) An identification of the legally marketed device to which the
submitter claims equivalence. A legally marketed device to which a new
device may be compared for a determination regarding substantial
equivalence is a device that was legally marketed prior to May 28, 1976,
or a device which has been reclassified from class III to class II or I
(the predicate), or a device which has been found to be substantially
equivalent through the 510(k) premarket notification process;
(4) A description of the device that is the subject of the premarket
notification submission, such as might be found in the labeling or
promotional material for the device, including an explanation of how the
device functions, the scientific concepts that form the basis for the
device, and the significant physical and performance characteristics of
the device, such as device design, material used, and physical
properties;
(5) A statement of the intended use of the device that is the
subject of the premarket notification submission, including a general
description of the diseases or conditions that the device will diagnose,
treat, prevent, cure, or mitigate, including a description, where
appropriate, of the patient population for which the device is intended.
If the indication statements are different from those of the legally
marketed device identified in paragraph (a)(3) of this section, the
510(k) summary shall contain an explanation as to why the differences
are not critical to the intended therapeutic, diagnostic, prosthetic, or
surgical use of the device, and why the differences do not affect the
safety and effectiveness of the device when used as labeled; and
(6) If the device has the same technological characteristics (i.e.,
design, material, chemical composition, energy source) as the predicate
device identified in paragraph (a)(3) of this section, a summary of the
technological characteristics of the new device in comparison to those
of the predicate device. If the device has different technological
characteristics from the predicate device, a summary of how the
technological characteristics of the device compare to a legally
marketed device identified in paragraph (a)(3) of this section.
(b) 510(k) summaries for those premarket submissions in which a
determination of substantial equivalence is also based on an assessment
of performance data shall contain the following information:
(1) A brief discussion of the nonclinical tests submitted,
referenced, or relied on in the premarket notification submission for a
determination of substantial equivalence;
(2) A brief discussion of the clinical tests submitted, referenced,
or relied on in the premarket notification submission for a
determination of substantial equivalence. This discussion shall include,
where applicable, a description of the subjects upon whom the device was
tested, a discussion of the safety or effectiveness data obtained from
the testing, with specific reference to adverse effects and
complications, and any other information from the clinical testing
relevant to a determination of substantial equivalence; and
(3) The conclusions drawn from the nonclinical and clinical tests
that demonstrate that the device is as safe, as effective, and performs
as well as or better than the legally marketed device identified in
paragraph (a)(3) of this section.
(c) The summary should be in a separate section of the submission,
beginning on a new page and ending on a page not shared with any other
section of the premarket notification submission, and should be clearly
identified as a ``510(k) summary.''
(d) Any other information reasonably deemed necessary by the agency.
[57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994]
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Sec. 807.93 Content and format of a 510(k) statement.
(a)(1) A 510(k) statement submitted as part of a premarket
notification shall state as follows:
I certify that, in my capacity as (the position held in company by
person required to submit the premarket notification, preferably the
official correspondent in the firm), of (company name), I will make
available all information included in this premarket notification on
safety and effectiveness within 30 days of request by any person if the
device described in the premarket notification submission is determined
to be substantially equivalent. The information I agree to make
available will be a duplicate of the premarket notification submission,
including any adverse safety and effectiveness information, but
excluding all patient identifiers, and trade secret and confidential
commercial information, as defined in 21 CFR 20.61.
(2) The statement in paragraph (a)(1) of this section should be
signed by the certifier, made on a separate page of the premarket
notification submission, and clearly identified as ``510(k) statement.''
(b) All requests for information included in paragraph (a) of this
section shall be made in writing to the certifier, whose name will be
published by FDA on the list of premarket notification submissions for
which substantial equivalence determinations have been made.
(c) The information provided to requestors will be a duplicate of
the premarket notification submission, including any adverse
information, but excluding all patient identifiers, and trade secret and
confidential commercial information as defined in Sec. 20.61 of this
chapter.
[59 FR 64295, Dec. 14, 1994]
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Sec. 807.94 Format of a class III certification.
(a) A class III certification submitted as part of a premarket
notification shall state as follows:
I certify, in my capacity as (position held in company), of (company
name), that I have conducted a reasonable search of all information
known or otherwise available about the types and causes of safety or
effectiveness problems that have been reported for the (type of device).
I further certify that I am aware of the types of problems to which the
(type of device) is susceptible and that, to the best of my knowledge,
the following summary of the types and causes of safety or effectiveness
problems about the (type of device) is complete and accurate.
(b) The statement in paragraph (a) of this section should be signed
by the certifier, clearly identified as ``class III certification,'' and
included at the beginning of the section of the premarket notification
submission that sets forth the class III summary.
[59 FR 64296, Dec. 14, 1994]
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Sec. 807.95 Confidentiality of information.
(a) The Food and Drug Administration will disclose publicly whether
there exists a premarket notification submission under this part:
(1) Where the device is on the market, i.e., introduced or delivered
for introduction into interstate commerce for commercial distribution;
(2) Where the person submitting the premarket notification
submission has disclosed, through advertising or any other manner, his
intent to market the device to scientists, market analysts, exporters,
or other individuals who are not employees of, or paid consultants to,
the establishment and who are not in an advertising or law firm pursuant
to commercial arrangements with appropriate safeguards for secrecy; or
(3) Where the device is not on the market and the intent to market
the device has not been so disclosed, except where the submission is
subject to an exception under paragraph (b) or (c) of this section.
(b) The Food and Drug Administration will not disclose publicly the
existence of a premarket notification submission for a device that is
not on the market and where the intent to market the device has not been
disclosed for 90 days from the date of receipt of the submission, if:
(1) The person submitting the premarket notification submission
requests in the submission that the Food and Drug Administration hold as
confidential commercial information the intent to market the device and
submits a written certification to the Commissioner:
(i) That the person considers his intent to market the device to be
confidential commercial information;
(ii) That neither the person nor, to the best of his knowledge,
anyone else, has disclosed through advertising or any other manner, his
intent to market the device to scientists, market analysts, exporters,
or other individuals, except employees of, or paid consultants to, the
establishment or individuals in an advertising or law firm pursuant to
commercial arrangements with appropriate safeguards for secrecy;
(iii) That the person will immediately notify the Food and Drug
Administration if he discloses the intent to market the device to
anyone, except employees of, or paid consultants to, the establishment
or individuals in an advertising or law firm pursuant to commercial
arrangements with appropriate safeguards for secrecy;
(iv) That the person has taken precautions to protect the
confidentiality of the intent to market the device; and
(v) That the person understands that the submission to the
government of false information is prohibited by 18 U.S.C. 1001 and 21
U.S.C. 331(q); and
(2) The Commissioner agrees that the intent to market the device is
confidential commercial information.
(c) Where the Commissioner determines that the person has complied
with the procedures described in paragraph (b) of this section with
respect to a device that is not on the market and where the intent to
market the device has not been disclosed, and the Commissioner agrees
that the intent to market the device is confidential commercial
information, the Commissioner will not disclose the existence of the
submission for 90 days from the date of its receipt by the agency. In
addition, the Commissioner will continue not to disclose the existence
of such a submission for the device for an additional time when any of
the following occurs:
(1) The Commissioner requests in writing additional information
regarding the device pursuant to Sec. 807.87(h), in which case the
Commissioner will not disclose the existence of the submission until 90
days after the Food and Drug Administration's receipt of a complete
premarket notification submission;
(2) The Commissioner determines that the device intended to be
introduced is a class III device and cannot be marketed without
premarket approval or reclassification, in which case the Commissioner
will not disclose the existence of the submission unless a petition for
reclassification is submitted under section 513(f)(2) of the act and its
existence can be disclosed under Sec. 860.5(d) of this chapter; or
(d) FDA will make a 510(k) summary of the safety and effectiveness
data available to the public within 30 days of the issuance of a
determination that the device is substantially equivalent to another
device. Accordingly, even when a 510(k) submitter has complied with the
conditions set forth in paragraphs (b) and (c) of this section,
confidentiality for a premarket notification submission cannot be
granted beyond 30 days after FDA issues a determination of equivalency.
(e) Data or information submitted with, or incorporated by reference
in, a premarket notification submission (other than safety and
effectiveness data that have not been disclosed to the public) shall be
available for disclosure by the Food and Drug Administration when the
intent to market the device is no longer confidential in accordance with
this section, unless exempt from public disclosure in accordance with
part 20 of this chapter. Upon final classification, data and information
relating to safety and effectiveness of a device classified in class I
(general controls) or class II (performance standards) shall be
available for public disclosure. Data and information relating
to safety and effectiveness of a device classified in class III
(premarket approval) that have not been released to the public shall be
retained as confidential unless such data and information become
available for release to the public under Sec. 860.5(d) or other
provisions of this chapter.
[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 57
FR 18067, Apr. 28, 1992; 59 FR 64296, Dec. 14, 1994]
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Sec. 807.97 Misbranding by reference to premarket notification.
Submission of a premarket notification in accordance with this
subpart, and a subsequent determination by the Commissioner that the
device intended for introduction into commercial distribution is
substantially equivalent to a device in commercial distribution before
May 28, 1976, or is substantially equivalent to a device introduced into
commercial distribution after May 28, 1976, that has subsequently been
reclassified into class I or II, does not in any way denote official
approval of the device. Any representation that creates an impression of
official approval of a device because of complying with the premarket
notification regulations is misleading and constitutes misbranding.
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Sec. 807.100 FDA action on a premarket notification.
(a) After review of a premarket notification, FDA will:
(1) Issue an order declaring the device to be substantially
equivalent to a legally marketed predicate device;
(2) Issue an order declaring the device to be not substantially
equivalent to any legally marketed predicate device;
(3) Request additional information; or
(4) Withhold the decision until a certification or disclosure
statement is submitted to FDA under part 54 of this chapter.
(5) Advise the applicant that the premarket notification is not
required. Until the applicant receives an order declaring a device
substantially equivalent, the applicant may not proceed to market the
device.
(b) FDA will determine that a device is substantially equivalent to
a predicate device using the following criteria:
(1) The device has the same intended use as the predicate device;
and
(2) The device:
(i) Has the same technological characteristics as the predicate
device; or
(ii)(A) Has different technological characteristics, such as a
significant change in the materials, design, energy source, or other
features of the device from those of the predicate device;
(B) The data submitted establishes that the device is substantially
equivalent to the predicate device and contains information, including
clinical data if deemed necessary by the Commissioner, that demonstrates
that the device is as safe and as effective as a legally marketed
device; and
(C) Does not raise different questions of safety and effectiveness
than the predicate device.
(3) The predicate device has not been removed from the market at the
initiative of the Commissioner of Food and Drugs or has not been
determined to be misbranded or adulterated by a judicial order.
[57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]
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