82 FR 50144 - De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 208 (October 30, 2017)

Page Range		50144-50145
FR Document		2017-23492

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide guidance on the process for the submission and review of a De Novo classification request (hereafter a ``De Novo request'') under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the De Novo classification process. FDA is issuing this guidance to also provide updated recommendations for interactions with FDA related to the De Novo classification process, including what information to submit when seeking a path to market via the De Novo classification process. This guidance replaces ``New Section 513(f)(2)--Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff,'' dated February 19, 1998.

Federal Register, Volume 82 Issue 208 (Monday, October 30, 2017)

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50144-50145]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-23492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0689]

De Novo Classification Process (Evaluation of Automatic Class III
Designation); Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``De Novo Classification
Process (Evaluation of Automatic Class III Designation).'' The purpose
of this document is to provide guidance on the process for the
submission and review of a De Novo classification request (hereafter a
``De Novo request'') under the Federal Food, Drug, and Cosmetic Act
(the FD&C Act), also known as the De Novo classification process. FDA
is issuing this guidance to also provide updated recommendations for
interactions with FDA related to the De Novo classification process,
including what information to submit when seeking a path to market via
the De Novo classification process. This guidance replaces ``New
Section 513(f)(2)--Evaluation of Automatic Class III Designation,
Guidance for Industry and CDRH Staff,'' dated February 19, 1998.

DATES: The announcement of the guidance is published in the Federal
Register on October 30, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-D-0689 for ``De Novo Classification Process (Evaluation of
Automatic Class III Designation); Guidance for Industry and Food and
Drug Administration Staff; Availability.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled ``De
Novo Classification Process (Evaluation of Automatic Class III
Designation)'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002 or the Office of Communication, Outreach,
and Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,

[[Page 50145]]

Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Sergio de del Castillo, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002,
301-796-6419; and Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 301-240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

The automatic class III designation for devices of a new type
occurs by operation of law and without any action by FDA, regardless of
the level of risk posed. Any device that is of a new type that was not
in commercial distribution before May 28, 1976, is automatically
classified as, and remains within, class III and requires premarket
approval unless and until FDA takes an action to classify or reclassify
the device section 513(f)(1) of the FD&C Act (21 U.S.C. 360c(f)(1)). We
refer to these devices as ``postamendments devices'' because they were
not in commercial distribution prior to the date of enactment of the
Medical Device Amendments of 1976.
FDA may classify a device through the De Novo classification
process, which is the pathway authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). A person may submit a De Novo request
after submitting a premarket notification under section 510(k) of the
FD&C Act and receiving a not substantially equivalent (NSE)
determination (section 513(f)(2)(A)(i) of the FD&C Act). A person may
also submit a De Novo request without first submitting a premarket
notification under section 510(k), if the person determines that there
is no legally marketed device upon which to base a determination of
substantial equivalence (section 513(f)(2)(A)(ii) of the FD&C Act).
Upon receipt of a De Novo request, FDA is required to classify the
device by written order (section 513(f)(2)(A)(iii) of the FD&C Act).
The classification will be according to the criteria under section
513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Per section
513(f)(2)(B)(i) of the FD&C Act, the classification is the initial
classification of the device for the purposes of section 513(f)(1) of
the FD&C Act.
We believe De Novo classification will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens. When FDA
classifies a device into class I or II via the De Novo classification
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (section 513(f)(2)(B)(i)). As a result,
other device sponsors do not have to submit a De Novo request or PMA in
order to market a substantially equivalent device (see 21 U.S.C.
360c(i), defining ``substantial equivalence''). Instead, sponsors can
use the less-burdensome 510(k) process, when applicable, as a pathway
to market their device.
FDA is issuing this document to provide guidance on the process for
the submission and review of a De Novo request under section 513(f)(2)
of the FD&C Act, also known as the De Novo classification process. This
guidance also provides updated recommendations for interactions with
FDA related to the De Novo classification process, including what
information to submit when seeking a path to market via the De Novo
classification process. This guidance will provide clarity regarding
the Agency's review process and expectations for information to be
submitted in a De Novo request and ensures predictability and
consistency for sponsors.
FDA considered comments received on the draft guidance that
appeared in the Federal Register (79 FR 47651) of August 14, 2014. FDA
revised the guidance as appropriate in response to the comments. This
document supersedes ``New Section 513(f)(2)--Evaluation of Automatic
Class III Designation, Guidance for Industry and CDRH Staff'' dated
February 19, 1998.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the De Novo Classification Process
(Evaluation of Automatic Class III Designation). It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' may send an
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic
copy of the document. Please use the document number 1760 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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
collections of information in the guidance ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844. The collections of
information in the guidance document ``Requests for Feedback on Medical
Device Submissions: The Pre-Submission Program and Meetings with Food
and Drug Administration Staff'' have been approved under OMB control
number 0910-0756. The collections of information in 21 CFR part 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; and the collections of information in 21
CFR part 801 have been approved under OMB control number 0910-0485.

Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23492 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P

Document Created: 2017-10-28 00:28:30
Document Modified: 2017-10-28 00:28:30

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on October 30, 2017.
Contact		Sergio de del Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002, 301-796-6419; and Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 301-240-402-7911.
FR Citation		82 FR 50144

82 FR 50144 - De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 208 (October 30, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration