Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
| Published date | 02 July 2019 |
| Citation | 84 FR 31600 |
| Record Number | 2019-14066 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 84 Issue 127 (Tuesday, July 2, 2019)
[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Notices]
[Pages 31600-31602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14066]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6069]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; De Novo
Classification Process (Evaluation of Automatic Class III Designation)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
1, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0844.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
De Novo Classification Process (Evaluation of Automatic Class III
Designation)
OMB Control Number 0910-0844--Revision
The draft guidance entitled ``Acceptance Review for De Novo
Classification Requests'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests) explains 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. The 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 was issued to be responsive to an explicit
deliverable identified in the Medical Device User Fee Amendments of
2017.
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.
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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(2)).
In the Federal Register of October 30, 2017 (82 FR 50135), FDA
published a 60-day notice requesting public comment on the draft
guidance and the proposed collection of information. We received
various comments on the draft guidance. We describe and respond to the
comments related to the proposed information collection in the
following paragraphs. We have numbered each comment to help distinguish
between different comments. We have grouped similar comments together
under the same number, and, in some cases, we have separated different
issues discussed in the same set of comments and designated them as
distinct comments for purposes of our responses. The number assigned to
each comment or comment topic is purely for organizational purposes and
does not signify the comment's value or importance or the order in
which comments were received.
(Comment 1) One comment proposed that, in section VII.B of the
draft guidance (``Prior Submission(s) Relevant to the De Novo Request
Under Review''), FDA revise the phrase ``For certain De Novo requests,
the requester may have previously provided other submissions for the
same device for which FDA provided feedback related to the data or
information needed to support De Novo classification (e.g., a pre-
submission request, investigational device exemption, prior Not
Substantially Equivalent (NSE) determination, or prior 510(k) or De
Novo that was deleted or withdrawn)'' to read, ``For certain De Novo
requests, the requester may have previously provided other submissions,
or there may be related FDA correspondence or other relevant
information for the same device, for which FDA provided feedback
related to the data or information needed to support De Novo
classification . . .'' The commenter noted that there may be informal
correspondence that is pertinent to the De Novo and this should be
explicitly requested in the ``Recommended Content Checklist'' in
Appendix B.
(Response 1) FDA does not agree with the proposed revision. This
element was intended to specifically focus on pertinent premarket
submissions and formal communications that have undergone supervisory
review.
(Comment 2) One comment suggested that elements identified as ``N/
A'' should require an accompanying rationale because an inadvertent
selection of a N/A answer may result in a ``Refuse to Accept'' (RTA)
decision.
(Response 2) We do not agree with this comment. Selection of ``N/
A'' for any element would not lead to an RTA decision. As explained in
section VI.C of the guidance, ``. . . the item should receive an answer
of ``yes'' or ``N/A'' for the De Novo request to be accepted for
substantive review.''
(Comment 3) Two commenters suggested that the preliminary questions
in Appendix A (``Acceptance Checklist
[[Page 31601]]
for De Novo Classification Requests'') of the guidance should be
removed and included in a document to be used by FDA reviewers or
should clarify that these are to be completed by FDA personnel only.
FDA recommends that requesters complete the checklists in Appendices A
and B (``Recommended Content Checklist for De Novo Classification
Requests''); however, the preliminary questions are intended for FDA
reviewers.
(Response 3) We do not agree with these commenters. The
instructions for the Preliminary Questions within the checklist in
Appendix A clearly state that ``Boxes checked in this section represent
FDAs preliminary assessment of these questions at the time of
administrative review.''
(Comment 4) Two commenters proposed that the Organizational
Elements in Appendix A be removed or included in Appendix B instead.
The commenters noted that these organizational elements should not
result in an RTA designation and, as such, should not be present in
Appendix A.
(Response 4) We decline to make this change. These are important
administrative elements that will allow the FDA reviewer to determine
if the submission is sufficiently organized in order to perform the
subsequent RTA review.
(Comment 5) Two commenters proposed that, in Appendix A of the
draft guidance, under the section ``Elements of a Complete De Novo
Request,'' we remove the second and third paragraphs from Question 1a,
or move them to Appendix B. Question 1a requests ``[a] description of
the technology (features, materials, and principles of operation) for
achieving the intended effect.'' The commenters assert that the second
and third paragraphs begin to assess ``the sufficiency'' of the device
description by necessitating detailed device information for acceptance
of the De Novo request. In addition, the commenter believes the
language in the second paragraph (``Where necessary to describe the
device, . . .'') is subjective and would necessitate a substantive
review of the device description to determine adequacy.
(Response 5) We do not agree with the commenters' description.
Because of the wide variety of device types reviewed through the De
Novo Program, the reviewer needs flexibility to determine if
engineering or representative drawings are necessary for a complete
device description. This element is only requesting the inclusion of
such information; it is not asking the reviewer to determine the
adequacy of the information.
(Comment 6) One comment proposed that, in Appendix A of the draft
guidance, under section C of ``Elements of a Complete De Novo
Request,'' FDA remove the phrase ``detailed information and'' in the
prefaces to questions 3 through 7. The commenter believes that this
request for ``detailed information'' exceeds the intention of the RTA
review which would simply assess the presence of information or a
rationale, if not present.
(Response 6) We do not agree with this suggestion. The language in
question states ``To the extent that the submission relies upon the
following information to provide detailed information and reasons for
the recommended classification, the De Novo request provides the
following . . .''--therefore the request for the purposes of the
Checklist is not for the ``detailed information,'' per se, but rather
identifying aspects of the submission for which detailed information
will be evaluated during substantive review. Consistent with the policy
outlined in the guidance, reviewers will not conduct a detailed review
of such information during the RTA phase.
(Comment 7) A comment requested clarity on the extent of
information, and location of such information, to be included regarding
clinical studies conducted outside the United States.
(Response 7) The element requesting a summary and full study report
for clinical studies (Appendix B, Section E, Question 6) does not
require or specify the source of clinical study information. Therefore,
we disagree that additional revision to this element is necessary--this
pertains to clinical data from studies conducted either within or
outside the United States.
(Comment 8) A comment proposed we remove questions 2b and 2c from
section D of the Acceptance Checklist, requesting information to be
included as part of the Financial Certification (Form FDA 3454) and
Financial Disclosure (Form FDA 3455) forms. The commenter believes that
the requested information in these questions should be reviewed during
substantive review of the De Novo request.
(Response 8) We do not agree. These questions are ensuring that
required content in the Financial Certification Forms are included for
review. We are not assessing the adequacy of the content.
(Comment 9) A comment proposed that we move element 1 in Appendix
B, Section A, requesting ``all content used to support the De Novo
request is written in English,'' to the Acceptance Checklist in
Appendix A. One would expect that content be provided in English in
order to conduct a substantive review of the De Novo request.
(Response 9) We decline to make this change. There is no statutory
requirement for providing documentation in English.
(Comment 10) A comment recommends that further guidance
``explicitly and specifically incorporate least burdensome concepts.''
The commenter believes that the draft guidance outlines processes that
may not embody least burdensome principles.
(Response 10) We have not made changes based on this comment. FDA
defines least burdensome to be the minimum amount of information
necessary to adequately address a regulatory question or issue through
the most efficient manner at the right time. The least burdensome
provisions and guiding principles do not change the applicable
regulatory or statutory requirements. We believe the recommendations in
the guidance are consistent with the least burdensome provisions and
guiding principles, and we apply them in identifying what FDA believes
to be the minimum information that the Agency relies on to complete
premarket submission review in the most efficient manner. For
information on the least burdensome provisions, refer to FDA's guidance
for industry, ``The Least Burdensome Provisions: Concept and
Principles'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles).
(Comment 11) A comment requested that FDA provide clarification on
the RTA process, as the draft guidance suggests a De Novo request could
be refused based upon ``immaterial issues.'' The commenter recommends
addition of a ``materiality standard'' that would limit refusal to
accept a De Novo request ``to instances where the missing information
is both material and relevant to the assessment of the safety or
efficiency [sic]of the device.''
(Response 11) We consider the ``materiality standard'' that the
commenter proposes, i.e., that the scope for denial of a review is
limited to instances where the missing information is both material and
relevant to the assessment of the safety or effectiveness of the
device, to be the fundamental basis for the Acceptance Checklist in
Appendix A. Elements requested in Appendix A are required by statute
and applicable regulations and, as such, we
[[Page 31602]]
consider these to be material and relevant to the substantive review of
the De Novo request.
(Comment 12) One comment proposed that FDA staff should be able to
use discretion in order to request missing checklist items
interactively, rather than to RTA when there are one or more items
missing from the Acceptance Checklist as described in section III.A of
the guidance. This would aid in ensuring a least burdensome approach
was applied to this process.
(Response 12) We do not believe that revisions are necessary in
response to this comment. Within section III.A, the guidance states
that ``FDA staff also has discretion to request missing checklist items
interactively from requesters during the RTA review. Interaction during
the RTA reviews is dependent on FDA staff's determination that
outstanding issues are appropriate for interactive review and that
adequate time is available for the requester to provide supporting
information and for FDA staff to assess responses.''
We believe the recommendations in the guidance are consistent with
the least burdensome provisions and guiding principles, and we apply
them in identifying what FDA believes to be the minimum information
that the Agency relies on to complete premarket submission review in
the most efficient manner. For information on the least burdensome
provisions, refer to FDA's guidance, ``The Least Burdensome Provisions:
Concept and Principles.''
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
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De Novo requests
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De Novo request under 21 U.S.C. 513(f)(2)(A)(i):
CDRH................................................ 2 1 2 100 200
CBER................................................ 1 1 1 100 100
De Novo request under 21 U.S.C. 513(f)(2)(A)(ii):
CDRH................................................ 56 1 56 180 10,080
CBER................................................ 1 1 1 180 180
Acceptance Checklist................................ 60 1 60 1 60
Recommended Content Checklist....................... 60 1 60 1 60
Total De Novo requests.................................. .............. .............. 60 .............. 10,680 $7,278
Request for withdrawal \2\.............................. 5 1 5 10 50 5
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Total............................................... .............. .............. .............. .............. 10,730 7,283
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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.
Based on updated program data and trends, we expect to receive
approximately 60 De Novo requests per year. We have not changed our
estimates of the Average Burden per Response for De Novo requests.
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.
Approved operating and maintenance costs for a De Novo request
include printing, shipping, and eCopy costs. We have updated the
operating and maintenance costs to account for the updated burden
estimate for De Novo requests (resulting in an increase of $970 to the
total estimated operating and maintenance costs). However, 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.
The operating and maintenance cost for a De Novo submission
includes the cost of printing, shipping, and the eCopy. We estimate the
cost burden for a De Novo submission, including the Acceptance
Checklist and Recommended Content Checklist, to be $121.30 ($90
printing + $30 shipping + $1.30 eCopy). The annual cost estimate for De
Novo submissions is $7,278 (60 submissions x $121.30). We estimate the
cost for a request for withdrawal to be $1 (rounded) ($0.09 printing 1
page + $0.03 shipping + $1.30 eCopy). The annual cost estimate for
requests for withdrawal is $5.
Our estimated burden for the information collection reflects an
overall increase of 3,400 hours. We attribute this adjustment to the
addition of the Acceptance Checklist and the Recommended Content
Checklist and to an increase in the number of submissions we received
during the approval period. For clarity, we have separated the
Acceptance Checklist and Recommended Content Checklist into distinct
line-items in table 1.
Dated: June 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14066 Filed 7-1-19; 8:45 am]
BILLING CODE 4164-01-P
