[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]


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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.

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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:
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    \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.
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     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\
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    \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.
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    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.
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    \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).
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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

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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.
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    \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.
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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\
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    \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.
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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:
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    \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.
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     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

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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