[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50135-50138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23500]


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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Acceptance Review for De Novo Classification Requests; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Acceptance Review for 
De Novo Classification Requests.'' The purpose of this draft guidance 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 This draft guidance discusses De Novo acceptance 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). This draft guidance is not final nor is it in effect 
at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 29, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2017-D-6069 for ``Acceptance Review for De Novo Classification 
Requests; Draft 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

[[Page 50136]]

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 draft 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 (CDRH), 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 (CBER), 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 section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (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. A person may submit a De Novo request after submitting a 
premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) 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. 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 less-
burdensome 510(k) process, when applicable, as a pathway to market 
their device.
    FDA is issuing this draft 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, when 
finalized. Therefore, if all criteria necessary to meet a minimum 
threshold of acceptability for De Novo requests as outlined in this 
guidance, when finalized, are not included in a De Novo request 
received by FDA before or up to 60 days after the publication of this 
guidance, when finalized, CDRH staff does not generally intend to 
refuse to accept.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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

[[Page 50137]]

it satisfies the requirements of the applicable statutes and 
regulations. This draft guidance is not subject to Executive Order 
12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. 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

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3502), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c) (2)(A) of the PRA (44 U.S.C. 3506 
(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed revision of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

De Novo Classification Process (Evaluation of Automatic Class III 
Designation)

OMB Control Number 0910-0844--Revision

    To aid in the acceptance review, the guidance recommends that 
requesters complete and submit with their De Novo request an Acceptance 
Checklist that identifies the location of supporting information for 
each acceptance element and a Recommended Content Checklist that 
identifies the location of supporting information for each recommended 
content element. Therefore, we request revision of OMB control number 
0910-0844, ``De Novo Classification Process (Evaluation of Automatic 
Class III Designation)'' to include the Acceptance Checklist and the 
Recommended Content Checklist in the hourly burden estimate for De Novo 
requests.
    We previously estimated the average burden per response for a De 
Novo request under 21 U.S.C. 513(f)(2)(i) to be 100 hours and under 21 
U.S.C. 513(f)(2)(ii) to be 180 hours. We estimate that it will take 
approximately 1 hour to prepare an Acceptance Checklist and 1 hour to 
prepare a Recommended Content Checklist. Our estimate assumes that each 
De Novo request will include both checklists. Therefore, we estimate 
the revised average burden per response for a De Novo request under 21 
U.S.C. 513(f)(2)(i) to be 102 hours and under 21 U.S.C. 513(f)(2)(ii) 
to be 182 hours. The revision results in a 104-hour increase in the 
total burden estimate. The average burden per response is based on 
estimates by FDA administrative and technical staff that are familiar 
with the requirements for submission of a De Novo request (and related 
materials), have consulted and advised manufacturers on submissions, 
and have reviewed the documentation submitted.
    Approved operating and maintenance costs for a De Novo request 
include printing, shipping, and eCopy costs. We believe any increase of 
the operating and maintenance cost resulting from the addition of the 
Acceptance Checklist and Recommended Content Checklist to be de 
minimis. Therefore, we are not requesting revision of the operating and 
maintenance cost estimate for OMB control number 0910-0844.
    Respondents to the information collection are medical device 
manufacturers seeking to market medical device products through 
submission of a De Novo classification request under section 513(f)(2) 
of the FD&C Act.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                                                              Total
                                                            Number of       Number of     Total annual   Average burden                   operating and
                        Activity                           respondents    responses per     responses     per response     Total hours     maintenance
                                                                           respondent                                                       costs \2\
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                                                      De Novo Request Under 21 U.S.C. 513(f)(2)(i)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH...................................................              25               1              25             102           2,550  ...............
CBER...................................................               1               1               1             102             102  ...............
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                                                      De Novo Request Under 21 U.S.C. 513(f)(2)(ii)
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CDRH...................................................              25               1              25             182           4,550  ...............
CBER...................................................               1               1               1             182             182  ...............
                                                        ------------------------------------------------------------------------------------------------
    Total De Novo requests.............................  ..............  ..............              52  ..............           7,384           $6,308
Request for withdrawal\2\..............................               5               1               5              10              50               $5
                                                        ------------------------------------------------------------------------------------------------

[[Page 50138]]

 
        Total..........................................  ..............  ..............  ..............  ..............           7,434           $6,313
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\1\ There are no capital costs associated with this collection of information.
\2\ No change from approved information collection. This information is retained for the convenience of the reader.


    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23500 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P