[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
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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
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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 [email protected] 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:
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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]
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