Document issued on: April 6,
2012
The draft of this document was issued on April 29,
2010.
OMB Control No. 0910-0705
Expiration Date:
3/31/2015
See additional PRA statement in Section VIII of this
guidance
For questions for the Center for Devices and Radiological Health regarding
this document contact the Premarket Notification (510(k)) Section at
301-796-5640.
For questions for the Center for Biologics Evaluation and Research regarding
this document contact the Office of Communication, Outreach and Development at
1-800-835-4709 or 301-827-1800.
 
|
U.S. Department of Health and Human Services
Food and
Drug Administration
Center for Devices and Radiological Health
Center for
Biologics Evaluation and Research |
Contains Nonbinding Recommendations
Preface
Public Comment
You may submit written comments and suggestions at
any time for Agency consideration to the Division of Dockets Management, Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD,
20852. Submit electronic comments to
http://www.regulations.gov. Identify all comments with the docket
number listed in the notice of availability that publishes in the Federal
Register. Comments may not be acted upon by the Agency until the document is
next revised or updated.
Additional copies are available from the Internet.
You may also send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic
copy of the guidance or send a fax request to 301-847-8419 to receive a hard
copy. Please use the document number (1615) to identify the guidance you are
requesting.
Copies of the guidance are also available from:
Guidance for Industry and Food and Drug
Administration Staff
FDA and Industry Procedures for Section 513(g)
Requests for Information under the Federal Food, Drug, and Cosmetic Act
| This guidance represents the Food and Drug
Administration's (FDA's) current thinking on this topic. It does not create or
confer any rights for or on any person and does not operate to bind FDA or the
public. You can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to discuss
an alternative approach, contact the FDA staff responsible for implementing this
guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this
guidance. |
I. Introduction
Purpose
The purpose of this guidance is to establish procedures for submitting,
reviewing and responding to requests for information regarding the class in
which a device has been classified or the requirements applicable to a device
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that are
submitted in accordance with section 513(g) of the FD&C Act, 21 U.S.C.
360c(g).
FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, guidances describe the Agency’s current
thinking on a topic and should be viewed only as recommendations, unless
specific regulatory or statutory requirements are cited. The use of the word
should in Agency guidances means that something is suggested or
recommended, but not required.
II. Statutory Requirements for Device Classification
Section 513(a) of the FD&C Act (21 U.S.C. 360c(a)) establishes three
classes of devices based on the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness: class I (general controls), class
II (special controls in addition to general controls), and class III (premarket
approval in addition to general controls).
Under section 513(f) of the FD&C Act (21 U.S.C.
360c(f)), post-amendments devices (devices that were not in commercial
distribution before May 28, 1976, the date the Medical Device Amendments were
enacted) are classified in Class III. However, FDA may reclassify a
post-amendments device (as Class I or II) or determine that such a device is
"substantially equivalent" (SE)
1 to either another post-amendments device that has been
classified into Class I or II or to a pre-amendments device for which premarket
approval is not required.
2 Thus, a post-amendments device may be subject to
regulation as a Class I or II device in certain circumstances, including
when:
- the device is within a type of device that has been classified into class I
or II and FDA has found the device to be SE to a device within such type;
- the device is within a type of pre-amendments device which is to be
classified under section 513(b) of the FD&C Act (21 U.S.C. 360c(b)) and FDA
has found the device to be SE to a device within such type (an unclassified
device type); or
- FDA has classified or reclassified the device type in class I or II in
accordance with sections 513(f)(2) or 513(f)(3) of the FD&C Act (21 U.S.C.
360c(f)(2), (3)).
Pursuant to section 513(d) of the FD&C Act (21 U.S.C. 360c(d)), FDA
promulgates classification regulations classifying devices by generic type. A
"generic type of device" is "a grouping of devices that do not differ
significantly in purpose, design, materials, energy source, function, or any
other feature related to safety and effectiveness, and for which similar
regulatory controls are sufficient to provide reasonable assurance of safety and
effectiveness." (See 21 CFR 860.3(i)). FDA has issued regulations classifying
the vast majority of pre-amendments devices (devices that were in commercial
distribution before May 28, 1976) by generic type of device. See 21 CFR 860.84.
Each classification regulation, located at 21 CFR parts 862-892, indicates in
which class (I, II, or III) FDA has classified the device type. While the great
majority of device classifications codified in 21 CFR parts 862-892 are of
pre-amendments devices, some of these classifications are of post-amendments
devices.
III. Obtaining Information About a Device
A. General Information
You can obtain information about device
classification and regulatory requirements applicable to a type of device in
several ways. FDA's device regulations may be found at 21 CFR parts 800 - 898;
the regulations classifying device types are located at 21 CFR parts 862 - 892.
The
CDRH
classification resources on the CDRH web site can help you quickly ascertain how
your device type may be classified. You can also obtain information about the
regulatory requirements that may apply to a particular type of device on FDA’s
web site (see resources below).
B. Section 513(g) Request for Information
Section 513(g) of the FD&C Act (21 U.S.C. 360c(g)) provides a means for
obtaining the agency's views about the classification and the regulatory
requirements that may be applicable to your particular device. This provision
states:
Within sixty days of the receipt of a written request of any person for
information respecting the class in which a device has been classified or the
requirements applicable to a device under this Act, the Secretary shall provide
such person a written statement of the classification (if any) of such device
and the requirements of this Act applicable to the device.
Section 513(g) governs requests "for information respecting the class in
which a device has been classified or the requirements applicable to a device
under [the] Act." Submissions that do not request such information are outside
the scope of section 513(g).
If, based solely on the information provided with a 513(g) Request for
Information, the product at issue does not appear to be a "device" within the
meaning of section 201(h) of the FD&C Act (21 U.S.C. 321(h)), FDA will so
inform the requester in our response. If, based solely on the information
provided with the request, the product does appear to be a "device" within
section 201(h) of the FD&C Act, FDA will generally provide the following
information regarding device classification and applicable FDA regulatory
requirements:
- the agency's assessment, based on the information submitted in the request,
as to the generic type of device (e.g., classification regulation) that the
requester's device appears to be within (if any);
- the class of devices within that generic type (and if there is more than one
class within that generic type, the particular class within which the
requestor's device appears to fall);
- whether a PMA, 510(k), or neither is required in order to market devices of
the particular class within that generic type;
- other requirements applicable to devices of the particular class within that
generic type;
- whether a guidance document has been issued regarding the exercise of
enforcement discretion over the particular class of devices within that generic
type;
- whether additional FDA requirements may apply, such as those applicable to
radiation-emitting products.
FDA does not review data related to substantial equivalence or safety and
effectiveness in a 513(g) Request for Information. FDA's responses to 513(g)
Requests for Information are not device classification decisions and do not
constitute FDA clearance or approval for marketing. Classification decisions and
clearance or approval for marketing require submissions under different sections
of the FD&C Act. The most common method of seeking a classification decision
is to submit a premarket notification in accordance with section 510(k) of the
FD&C Act (see 21 CFR part 807, subpart E - Premarket Notification
Procedures).
FDA’s response to a 513(g) Request for Information
will not address the specific types of nonclinical, animal, or clinical testing
appropriate to support clearance or approval of a marketing application (when
required). You may send a pre-submission to the Document Control Center for
review by the appropriate review branch to receive more specific information
about your specific testing recommendations (for CDRH, see
IDE Approval Process; for CBER, use contact information
supplied on the 513(g) Request for Information response letter ).
A 513(g) response does not constitute final Agency action, but provides
responsive information based on the information provided by the requestor.
C. Formal Jurisdictional Determinations within FDA
If it is unclear to you which Center has
jurisdiction over your product, including any combination product for which the
lead Center has not yet been determined, it may be appropriate to contact the
Office of Combination Products (OCP) to discuss your product's jurisdiction and
whether to submit a formal Request for Designation (RFD) under section 563 of
the FD&C Act ( 21 U.S.C. 360bbb-2) rather than submitting a 513(g) Request
for Information. The RFD process is used to obtain a formal agency determination
concerning the classification of a product as a drug, device, biological
product, or combination product subject to section 503(g) of the FD&C Act (
21 U.S.C. 353(g)),
3
and/or respecting which agency component(s) will regulate the product.
Contact information for OCP and comprehensive
information on how to write an RFD can be found at
Combination
Products.
III. Submitting a 513(g) Request for Information
A 513(g) Request for Information must be submitted in writing and should be
identified as a 513(g) Request for Information.
For submissions to CDRH, two copies of the request should be sent to:
U.S. Food and Drug Administration
Center for Devices and Radiological
Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
For submissions to CBER, two copies of the request should be sent to:
CBER 513(g) Coordinator
Quality Assurance Staff (HFM 4)
c/o Document
Control Center (HDM-99)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Suite 200N
Rockville, MD 20852
User Fees
The Act, as amended by the FDA Amendments Act of 2007 (FDAAA) (Public Law
110-85), requires FDA to collect user fees for 513(g) Requests for Information.
See section 738(a)(2)(A)(ix) of the FD&C Act (21 U.S.C. 379j(a)(2)(A)(ix)).
FDA may not accept your 513(g) for review until you have paid all fees owed,
including all required establishment registration fees. See section 738(f)(1) of
the FD&C Act (21 U.S.C. 379j(f)(1)). When FDA has received all fees owed,
our review of your 513(g) Request for Information will begin as of that
date.
As explained above, if the submission does not request information respecting
the class in which a device has been classified and/or the requirements
applicable to a device under the Act, it is not a Request for Information
governed by section 513(g) of the Act. Such requests do not require a response
from FDA. FDA intends to refund any user fee submitted with a request that is
not governed by section 513(g) of the FD&C Act.
For additional information on user fees for 513(g) requests for information
see the guidance document “User Fees and Refunds for 513(g) Requests for
Information.”
IV. Contents of a 513(g) Request for Information
The 513(g) Request for Information should contain the following:
- a cover letter,
- a description of the device,4
- a description of what the device is to be used for, and
- any proposed labeling or promotional material for the device and, as
applicable, any labeling or promotional material of a similar, legally marketed
device, if available.
Cover Letter
Your cover letter should identify your request as a “513(g) Request for
Information.” Your cover letter should include:
- the date of the request,
- the name of the device,
- your specific question(s) concerning the class in which a device has been
classified and/or the regulatory requirements applicable to a device,
- the requestor’s name, address, telephone number,
fax number, and email address,5 and
- the 513(g) requestor’s signature.
Description of the Device
As applicable, the description of the device should include:
- a list of materials and components used in/with the device,
- photographs, engineering drawings, and/or samples
of the device,6
- a summary of the device’s operational principles,
- a description of the type and amount of energy to be used or delivered by
the device, and
- a description of similar devices in commercial distribution in the United
States , if available.
Device Uses
You should include the following information:
- the disease or condition with respect to which the device is to be used
- prescription versus over-the-counter use,
- part of the body or type of tissue applied to or interacted with,
- frequency of use,
- physiological purpose (e.g., removes water from blood, transports blood,
etc.),
- patient population; and
- any other labeling information related to the patient use of the device.
Labeling
You should provide any proposed labeling, including proposed promotional
material for the device or any labeling or promotional material of a similar,
legally marketed device. If no proposed labeling is available for the described
device or for a similar legally marketed device, this should be noted in the
cover letter.
Additions to a 513(g) Request for Information
Once FDA has received your 513(g) Request for Information and user fee, you
may not modify that 513(g) request by subsequently adding a new question, use,
or technology. We would consider the addition of a new question, use, or
technology to a pending Request for Information to be a new 513(g) request
subject to an additional user fee, to which we intend to respond separately.
V. Reviewing a 513(g) Request for Information in CDRH
Upon receipt of the 513(g) Request for Information and the necessary user
fee, the Document Control Center (DCC) will assign a submission number to the
513(g) Request for Information and forward the request to a review branch in ODE
or OIVD for consideration. The DCC will send an "acknowledgement of receipt"
letter to the submitter of the 513(g) Request for Information. The 513(g)
Request for Information will generally be accepted for review by a branch in ODE
or OIVD. Staff from ODE or OIVD and other Offices within CDRH with appropriate
scientific and regulatory expertise will review the information provided, meet
as necessary, and draft a response for signature by the Director, ODE or
Director, OIVD. The response should be responsive to the regulatory question(s)
asked in the 513(g) Request for Information.
VI. Reviewing a 513(g) Request for Information in CBER
Upon receipt of the 513(g) Request for Information and the necessary user
fee, the Document Control Center (DCC) will forward the submission to the CBER
513(g) Coordinator who will assign a submission number to the 513(g) Request for
Information. The CBER 513(g) Coordinator will then review the 513(g) Request for
Information for completeness, confirm the request is for information respecting
the class in which a device has been classified and/or the requirements
applicable to a device under the FD&C Act, and send an "acknowledgement of
receipt" letter to the submitter of the 513(g) Request for Information. The
513(g) Request for Information will generally be assigned to one of the product
review offices for consideration. Staff from the assigned product review office
and other personnel within CBER with appropriate scientific and regulatory
expertise will review the information provided, meet as necessary, and draft a
response for signature by the director of the assigned product review office.
The response should be responsive to the regulatory question(s) asked in the
513(g) Request for Information.
VII. Responding to a 513(g) Request for Information in CDRH or CBER
Our response to a 513(g) Request for Information will be responsive to the
questions posed in the request. We intend to issue our response within 60 days
of receipt. Our response will generally fall into one of the following
categories indicating that, based solely on the information provided in the
513(g) Request for Information; it appears that the product you have identified
is:
- a device within the meaning of section 201(h) of
the FD&C Act, and
- appears to be a an unclassified pre-amendments device type and therefore is
subject to the 510(k) requirement;
- appears to be a post-amendments device type that has not yet been
re-classified and therefore is subject to the PMA requirement; or
- appears to be a device that is a classified device
type. We will generally identify the generic type of device (e.g.,
classification regulation) that your device appears to be within, the class of
devices within which your device appears to fall, and the type of submission, if
any, required in order to market devices of the particular class within that
generic type:
- Class I or II subject to the 510(k) requirement;
- Class I or II exempt from the 510(k) requirement;
- Class III subject to the 510(k) or PMA requirements; OR
- not a device,
- but may be another type of product regulated by FDA. In this case, we would
provide you with contact information for another component within FDA; or
- and appears not to be a product for which FDA has jurisdiction; OR
- a combination product where it is not clear which Center has primary
jurisdiction. If you would like to discuss further the assignment of this
product, we recommend you contact the Office of Combination Products.
If
your 513(g) Request for Information is incomplete and we
are unable to provide information regarding classification and/or applicable
requirements because you have not submitted sufficient information to us, we
intend to contact the submitter and request additional information. If FDA does
not receive a response within 30 days of our request, we may consider a 513(g)
to be withdrawn. In this instance, FDA may issue a notice of withdrawal.
VIII. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to
average 12 hours per response, including the time to review instructions, search
existing data sources, gather the data needed, and complete and review the
information collection. Send comments regarding this burden estimate or
suggestions for reducing this burden to:
510(k) Staff, Program Operations Staff, Office of Device Evaluation, Center
for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993.
This guidance also refers to currently approved collections of information
found in FDA regulations. The collections of information in 21 CFR 807 subpart E
have been approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814 have been approved under OMB control number
0910-0231; the collections of information in 21 CFR part 801 have been approved
under OMB control number 0910-0485; and the collections of information in 21 CFR
860.123 have been approved under OMB control number 0910-0138.
An
agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control
number. The OMB control number for this information collection is 0910-0705
(expires 3/31/2015).
1 Substantial equivalence
is defined at section 513(i) of the FD&C Act (21 U.S.C. 360c(i)). FDA
generally evaluates substantial equivalence on the basis of a premarket
notification submitted pursuant to section 510(k) of the FD&C Act (21 U.S.C.
360(k)). Certain devices are subject to a statutory exemption from the 510(k)
premarket notification requirement (see sections 510(l) and (m) of the FD&C
Act).
2 A pre-amendments
device for which premarket approval is not required could be a pre-amendments
device that has been classified into Class I or Class II, a pre-amendments
device that has been classified into Class III but for which a regulation under
section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring the submission
of an application for premarket approval (PMA) has not yet been issued, or a
pre-amendments device that has not yet been classified.
3 Combination
product is defined at 21 CFR 3.2(e).
4 A 513(g) Request
for Information should seek classification information and/or regulatory
requirements for a single product and may include multiple uses of the product.
Requests for classification information and regulatory requirements for multiple
products should be divided up so that a separate Request for Information and
user fee are submitted for each product.
5 You should
provide the contact information for a single point of contact. The contact
information should be associated with the person submitting the Request for
Information as the term person is defined in section 201(e) of the FD&C Act.
6 Any sample
device can be returned at the request of the submitter.
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