[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Notices]
[Pages 61605-61608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21835]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2274]
Medical Devices; Voluntary Total Product Life Cycle Advisory
Program Pilot
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA, Agency, or we) Center
for Devices and Radiological Health (CDRH or Center) is announcing its
voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot
that will begin in fiscal year (FY) 2023 with the initial phase,
hereafter referred to as the TAP Pilot Soft Launch. The TAP Pilot is
one of the commitments agreed to between FDA and industry as part of
the reauthorization of the Medical Device User Fee Amendments for FY
2023 through FY 2027 (MDUFA V). The long-term vision for TAP is to help
spur more rapid development and more rapid and widespread patient
access to safe, effective, high-quality medical devices of public
health importance. Over the course of MDUFA V, the voluntary TAP Pilot
is intended to demonstrate the feasibility and benefits of process
improvements to FDA's early interactions with participants and of FDA's
facilitation of interactions between participants and stakeholders that
support the vision for TAP.
DATES: Beginning January 1, 2023, FDA is seeking requests for
enrollment in the TAP Pilot Soft Launch for FY 2023. Either electronic
or written comments on this notice must be submitted by January 10,
2023 to ensure that the Agency considers your comment on this notice
before it begins work on the next phase of the TAP Pilot.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 10, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
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-2022-N-2274 for ``Medical Devices; Voluntary Total Product Life
Cycle
[[Page 61606]]
Advisory Program Pilot.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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 office
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Matthew Hillebrenner, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2302, Silver Spring MD 20993, 301-
796-6358, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
As part of the reauthorization of the MDUFA V,\1\ FDA committed to
establish the TAP Pilot during the course of MDUFA V.\2\ The long-term
vision for TAP is to help spur more rapid development and more rapid
and widespread patient access to safe, effective, high-quality medical
devices of public health importance. A mature TAP is also intended to
help ensure the sustained success of the Breakthrough Devices program
(see more information on this program below in Section I.C). Through
the TAP Pilot, as described in the MDUFA V commitment letter, FDA will
provide the following types of strategic engagement for innovative
devices of public health importance:
---------------------------------------------------------------------------
\1\ MDUFA V spans from FY 2023 through FY 2027. The fiscal year
runs from October 1 through September 30, so FY 2023 runs from
October 1, 2022 through September 30, 2023.
\2\ For more information on FDA's TAP Pilot, see the TAP Pilot
web page at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap.
---------------------------------------------------------------------------
Improving participants' experiences with FDA by providing
for more timely premarket interactions;
Enhancing the experience of all participants throughout
the device development and review process, including FDA staff;
Facilitating improved strategic decision-making during
device development, including earlier identification, assessment, and
mitigation of device development risk;
Facilitating regular, solutions-focused engagement between
FDA review teams, participants, and other stakeholders, such as
patients, providers, and payers, beginning early in device development;
and
Collaborating to better align expectations regarding
evidence generation, improve submission quality, and improve the
efficiency of the premarket review process (Ref. 1).\3\
---------------------------------------------------------------------------
\3\ For more information on the goals and objectives of the TAP
Pilot, see the MDUFA V commitment letter, MDUFA Performance Goals
and Procedures, Fiscal Years 2023 Through 2027, available at https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
---------------------------------------------------------------------------
Consistent with the MDUFA V commitment letter, FDA initially
intends to include only devices with a granted Breakthrough designation
in the TAP Pilot in FY 2023-FY 2025 and intends to include devices with
a granted Breakthrough designation or request for inclusion in the
Safer Technologies Program (STeP) in FY 2026-FY 2027. At this time,
devices regulated by the Center for Biologics Evaluation and Research
(CBER) are outside the scope of the TAP Pilot.\4\ In addition, given
the complexities involved with the review of combination products,\5\
including coordination with review staff outside of CDRH, we anticipate
that it will be difficult for sponsors of combination products to
benefit fully from the TAP Pilot. Therefore, at this time, we do not
intend to enroll combination products in the Pilot.
---------------------------------------------------------------------------
\4\ In the MDUFA V commitment letter, FDA committed to
conducting the TAP Pilot within Offices of Health Technology (OHTs),
which are offices that review devices regulated by CDRH.
\5\ See 21 CFR 3.2(e).
---------------------------------------------------------------------------
A. Enrollment and Pilot Expansion Schedule
To implement the TAP Pilot and in accordance with the MDUFA V
commitment letter, FDA intends to take a phased-enrollment approach
throughout the duration of MDUFA V. The first phase is the TAP Pilot
Soft Launch, which will be conducted during FY 2023 (Ref. 1). During
the TAP Pilot Soft Launch phase, FDA intends to enroll up to 15 devices
in the Office of Health Technology 2 (OHT2): Office of Cardiovascular
Devices. Selection of OHT2 for the TAP Pilot Soft Launch was based on
consideration of multiple factors, including OHT2's historical number
of granted Breakthrough designations, workload, staffing levels, and
expertise, as well as experience with review paradigms involving rapid
interactions, such as Early Feasibility Studies. For example, OHT2 has
granted 163 Breakthrough Device designations as of June 30, 2022, which
represents 23.7 percent of the 687 Breakthrough Device designations
granted by CDRH.
In subsequent fiscal years, FDA intends to expand the TAP Pilot to
enroll more devices and to include devices reviewed in other OHTs.\6\
Specifically, as stated in the MDUFA V commitment letter, in FY 2024,
the TAP Pilot will continue to support devices enrolled in the previous
fiscal year and will expand to enroll up to 45 additional devices in at
least two OHTs (i.e., up to 60 total devices enrolled through FY 2024).
In FY 2025, the TAP Pilot will continue to support devices enrolled in
previous fiscal years and will expand to enroll up to 65 additional
devices in at least four OHTs (i.e., up to 125 total devices enrolled
through FY 2025). In FY 2026 and FY 2027, the TAP Pilot will continue
to support devices enrolled in previous
[[Page 61607]]
fiscal years and will expand to enroll up to 100 additional devices
each fiscal year within existing OHTs or expand to additional OHTs,
depending on lessons learned from the FY 2023 to FY 2025 experience
(i.e., up to 225 total devices enrolled through FY 2026 and up to 325
total devices enrolled through FY 2027). For FY 2024-FY 2027, selection
of the OHTs will include consideration of the factors mentioned above
regarding the selection of OHT2 for the Soft Launch, experience from
prior years, and input from industry and other stakeholders (Ref. 1).
For FY 2024-FY 2027, FDA plans to announce the OHT(s) selected for
future participation in the TAP Pilot via the TAP Pilot web page no
later than 30 days prior to the start of each fiscal year.
---------------------------------------------------------------------------
\6\ During the TAP Pilot, if spaces remain available in
participating OHTs for any fiscal year, or if resources permit, FDA
may consider enrolling devices from OHTs not yet participating in
the TAP Pilot.
---------------------------------------------------------------------------
B. Enrollment in the TAP Pilot
FDA will inform potential participants of the TAP Pilot as part of
the Breakthrough designation process or request for inclusion in the
STeP process, as applicable. Eligible TAP Pilot participants will be
enrolled on a first-come, first-served basis. The Pilot's capacity for
additional participating devices and the number of participating OHTs
within CDRH will increase each fiscal year as described in Section I.A.
As noted above, at this time, devices regulated by CBER are outside the
scope of the TAP Pilot, and we do not intend to enroll combination
products in the Pilot.
FDA intends to enroll devices reviewed in a participating OHT in
the voluntary TAP Pilot using the following enrollment criteria,
consistent with the MDUFA V commitment letter:
1. Devices will be those with either a granted Breakthrough
designation or (during FY 2026 and FY 2027) a granted request for
inclusion in the Safer Technologies Program (STeP);
2. Potential participants will not have submitted a Pre-Submission
about the device after being granted a Breakthrough designation or
inclusion in STeP;
3. Devices will be early in their device development process (e.g.,
have not yet initiated a pivotal study for the device) at time of
enrollment; and
4. Each potential participant will have a maximum of one device
enrolled in the TAP Pilot per fiscal year.
Enrollment in the TAP Pilot, including in the Soft Launch, does not
change any statutory or regulatory requirements that may apply to the
TAP Pilot device or participant, including, but not limited to,
investigational device exemption (IDE) requirements under 21 CFR part
812; premarket notification requirements under 21 CFR part 807, subpart
E; premarket approval requirements under 21 CFR part 814; and/or De
Novo classification requirements under 21 CFR part 860, subpart D. It
is the sponsor's responsibility to ensure compliance with applicable
laws and regulations.
C. Procedures for Enrollment in the TAP Pilot
To have a device considered for enrollment in the voluntary TAP
Pilot, sponsors should submit an amendment to the Q-submission under
which their device was granted Breakthrough designation or (during FY
2026 and FY 2027) inclusion in STeP, with the following information:
1. A subject heading clearly indicating ``TAP Pilot Request for
Enrollment'';
2. Name and address of the device sponsor; and
3. The Q-Submission number under which the device proposed for
enrollment in the TAP Pilot was granted Breakthrough designation or
inclusion in STeP.
For more information on the Breakthrough Devices program, see FDA's
website, https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program, and FDA Guidance, Breakthrough
Devices Program (Ref. 2). For more information on STeP, see FDA's
website, https://www.fda.gov/medical-devices/how-study-and-market-your-device/safer-technologies-program-step-medical-devices and FDA
Guidance, Safer Technologies Program for Medical Devices (Ref. 3).
Following receipt of a request for enrollment in the TAP Pilot, FDA
intends to consider the request using the enrollment criteria outlined
in Section I.B if spaces remain available in the TAP Pilot for the
relevant fiscal year. Within 30 days of receipt, FDA intends to notify
the potential participant in writing whether or not the device has been
enrolled into the TAP Pilot. If a participant's device is enrolled into
the TAP Pilot, FDA will contact the participant to schedule an initial
meeting to provide an overview of the TAP Pilot processes,
expectations, and engagement opportunities. If, after review of a
request for enrollment, a device is not enrolled in the TAP Pilot, FDA
will identify the reason(s) for that decision.
As noted in Section I.B., eligible TAP Pilot participants will be
enrolled on a first-come, first-served basis, for which we plan to use
the date of receipt of requests for enrollment in each respective
fiscal year. To facilitate an orderly enrollment process, FDA does not
intend to consider requests to enroll in the TAP Pilot until the start
of the fiscal year in which the participant wishes to enroll. (For
example, beginning on October 1, 2023, FDA intends to consider requests
to enroll in the TAP Pilot for FY 2024.) If the maximum number of
devices has been enrolled for the fiscal year in which a request is
received, FDA intends to notify the sponsor submitting the request that
enrollment in the TAP Pilot has reached capacity for the current fiscal
year. FDA also intends to provide enrollment updates, including a
notification that we have reached capacity for a given fiscal year, on
the TAP Pilot web page.\7\
---------------------------------------------------------------------------
\7\ For more information on FDA's TAP Pilot, see the TAP Pilot
web page at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap.
---------------------------------------------------------------------------
D. Performance Metrics
In an effort to achieve the TAP Pilot objectives, FDA committed to
implement and track the following quantitative performance metrics \8\
beginning in FY 2024:
---------------------------------------------------------------------------
\8\ See section J.3 of the MDUFA V commitment letter, MDUFA
Performance Goals and Procedures, Fiscal Years 2023 Through 2027,
available at: https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
---------------------------------------------------------------------------
CDRH will engage in a teleconference with the participant
on requested topic(s) pertaining to the TAP device within 14 days of
the request for 90 percent of requests for interaction.
CDRH will provide written feedback on requested
biocompatibility and sterility topics(s) pertaining to the TAP device
within 21 days of the request for 90 percent of such requests for
written feedback.
CDRH will provide written feedback on requested topic(s)
pertaining to the TAP device other than biocompatibility and sterility
within 40 days of the request for 90 percent of requests for written
feedback.
During this voluntary TAP Pilot, CDRH staff intend to be available
to answer questions or address concerns that may arise. The TAP Pilot
Program participants may comment on and discuss their experiences with
the Center.
For informational purposes, FDA will conduct an assessment of the
TAP Pilot using an independent third party (or parties) to assess the
TAP Pilot. This assessment will include a participant survey and
quantitative and qualitative success metrics, starting in FY 2024, that
include, but are not limited to: (a) the extent to which FDA is
successful at meeting the quantitative goals described above; (b)
participant satisfaction with
[[Page 61608]]
the timeliness, frequency, quality, and efficiency of interactions with
and written feedback from FDA; (c) participant satisfaction with the
timeliness, frequency, quality, and efficiency of voluntary
interactions with non-FDA stakeholders facilitated by FDA (if
utilized); and (d) an overall assessment of the outcomes of the Pilot
and opportunities for improvement (Ref. 1).
II. Request for Comments
FDA understands that to make this program the most effective, we
will need additional feedback and suggestions from industry and other
stakeholders. FDA encourages all stakeholders to comment on the TAP
Pilot generally. The Agency is particularly interested in feedback on
the following topics:
1. TAP Pilot participation will expand to include additional
Offices of Health Technology (OHTs) in FY 2024 through FY 2027. In what
order do you believe additional OHTs should be included in the TAP
Pilot? Please provide the reasons/rationale/justification to support
your recommendations in your response.
2. The TAP Pilot is intended to facilitate improved strategic
decision-making and better align expectations regarding evidence
generation during device development, including through facilitating
interactions between TAP participants and stakeholders, such as
patients, providers, and payers. These interactions are voluntary and
may, for example, help provide a better understanding of the current
treatment options used to treat or manage a given condition, which
outcomes are most important to patients and providers, how a new
technology may fit into clinical care paradigms and patient lives, how
patients and providers consider tradeoffs between anticipated benefits
and risks, and the evidence that may help support clinical adoption and
coverage.
(1) What additional questions or topics could patients, providers,
and/or payers address that could help inform sponsors' strategic
decision-making?
(2) Are there specific patient, provider, or payer organizations
whose members may be well-suited and willing to provide insights
regarding evidence generation strategies to sponsors who wish to obtain
such input?
III. Paperwork Reduction Act of 1995
This notice 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. 3501-3521). The collections of information
regarding Q-Submissions have been approved under OMB control number
0910-0756.
IV. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. U.S. Food and Drug Administration, ``MDUFA Performance Goals and
Procedures, Fiscal Years 2023 Through 2027,'' available at https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v.
2. U.S. Food and Drug Administration, ``Breakthrough Devices
Program,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.
3. U.S. Food and Drug Administration, ``Safer Technologies Program
for Medical Devices,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices.
4. U.S. Food and Drug Administration, ``Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program,''
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program.
5. U.S. Food and Drug Administration, ``Total Product Life Cycle
Advisory Program (TAP),'' available at https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap/.
Dated: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21835 Filed 10-11-22; 8:45 am]
BILLING CODE 4164-01-P