[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50144-50145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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 [email protected] 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