Document ID: FDA-2017-D-6069-0009
Agency: fda
Document Type: Notice
Title: Acceptance Review for De Novo Classification Requests; Guidance for
Industry and Food and Drug Administration Staff; Availability
Posted Date: 2019-09-09T04:00Z

[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47310-47312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19350]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6069]

Acceptance Review for De Novo Classification Requests; 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 a final guidance entitled ``Acceptance Review for 
De Novo Classification Requests.'' The purpose of this guidance is to 
explain the procedures and criteria FDA intends to use in assessing 
whether a request for an evaluation of automatic class III designation 
(De Novo classification request or De Novo request) meets a minimum 
threshold of acceptability and should be accepted for substantive 
review. This guidance discusses De Novo acceptance review policies and 
procedures, ``Refuse to Accept'' principles, and the elements of the De 
Novo Acceptance Checklist and the Recommended Content Checklist and is 
being issued to be responsive to an explicit deliverable identified in 
the Medical Device User Fee Amendments of 2017 (MDUFA IV).

DATES: The announcement of the guidance is published in the Federal 
Register on September 9, 2019.

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

[[Page 47311]]

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-2017-D-6069 for ``Acceptance Review for De Novo Classification 
Requests.'' 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 
``Acceptance Review for De Novo Classification Requests'' 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, 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; or 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, 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 by the device. 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 under section 513(f)(1) of the Federal Food, 
Drug, and Cosmetic Act (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. 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. 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 enhances 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, 
after a De Novo request is granted, other device sponsors do not have 
to submit a De Novo request or premarket application under section 515 
of the FD&C Act (21 U.S.C. 360e)) in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), ``defining substantial 
equivalence''). Instead, other device sponsors can use the 510(k) 
process, when applicable, as a pathway to market their device.
    FDA is issuing this guidance to provide clarity regarding the 
Agency's expectations for information to be submitted in a De Novo 
request and ensure predictability and consistency for sponsors. 
Focusing the Agency's review resources on complete De Novo requests 
will provide a more efficient approach to ensuring that safe and 
effective medical devices reach patients as quickly as possible. 
Moreover, with the enactment of MDUFA IV, FDA agreed to issuance of 
draft and final guidance, which includes a submission checklist to 
facilitate a more efficient and timely review process to assist with 
new performance goals. Acceptance review therefore takes on additional 
importance in both encouraging quality applications from De Novo 
requesters and allowing the Agency to appropriately concentrate 
resources on complete applications.
    FDA anticipates that the Agency and industry may need a period of 
time to operationalize the policies within this guidance. Therefore, if 
all criteria necessary to meet a minimum threshold of acceptability for 
De Novo requests as

[[Page 47312]]

outlined in this guidance are not included in a De Novo request 
received by FDA before or up to 60 days after the publication of this 
guidance, FDA staff does not generally intend to refuse to accept.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of October 30, 2017 (82 FR 50144). FDA 
revised the guidance as appropriate in response to the comments.

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 ``Acceptance Review for De Novo 
Classification Requests.'' 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. This 
guidance document is also available at https://www.regulations.gov or 
from the Center for Biologics Evaluation and Research at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Acceptance Review for De Novo 
Classification Requests'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 16055 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 following FDA regulations, guidance, and forms have been approved 
by OMB as listed in the following table:

------------------------------------------------------------------------
  21 CFR Part; guidance; or FDA
              form                       Topic          OMB control No.
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``De Novo Classification Process  De Novo                      0910-0844
 (Evaluation of Automatic Class    classification
 III Designation)``.               process.
807, subpart E..................  Premarket                    0910-0120
                                   notification.
814, subparts A through E.......  Premarket approval.          0910-0231
800, 801, and 809...............  Medical Device               0910-0485
                                   Labeling
                                   Regulations.
3...............................  Combination                  0910-0523
                                   products; Request
                                   for Designation.
807, 812, and 814...............  Human Subject                0910-0741
                                   Protection;
                                   Acceptance of Data
                                   from Clinical
                                   Studies for
                                   Medical Devices.
54 (Forms FDA 3454 and 3455)....  Financial                    0910-0396
                                   disclosure by
                                   clinical
                                   investigators.
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    Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19350 Filed 9-6-19; 8:45 am]
BILLING CODE 4164-01-P