Notice2022-07451
Medical Device User Fee Amendments; Public Meeting; Request for Comments
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Published
April 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual public meeting entitled "Medical Device User Fee Amendments." The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2023 through 2027. MDUFA authorizes FDA to collect fees and use them for the process for the review of device applications. The current legislative authority for MDUFA expires September 30, 2022. At that time, new legislation will be required for FDA to continue collecting device user fees in future fiscal years. Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Full Text
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[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Pages 20436-20441]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07451]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0907]
Medical Device User Fee Amendments; Public Meeting; Request for
Comments
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a virtual public meeting entitled ``Medical Device User Fee
Amendments.'' The purpose of the meeting is to discuss proposed
recommendations for the
[[Page 20437]]
reauthorization of the Medical Device User Fee Amendments (MDUFA) for
fiscal years (FYs) 2023 through 2027. MDUFA authorizes FDA to collect
fees and use them for the process for the review of device
applications. The current legislative authority for MDUFA expires
September 30, 2022. At that time, new legislation will be required for
FDA to continue collecting device user fees in future fiscal years.
Following discussions with the device industry and periodic
consultations with public stakeholders, the Federal Food, Drug, and
Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for
the reauthorized program in the Federal Register, provide for a period
of 30 days for the public to provide written comments on such
recommendations, and hold a meeting at which the public may present its
views on such recommendations. FDA will then consider such public views
and comments and revise such recommendations as necessary.
DATES: The public meeting will be held virtually on April 19, 2022,
from 12 p.m. to 4:30 p.m. Eastern Time. Submit electronic or written
comments to the public docket by April 21, 2022.
ADDRESSES: Registration to attend this virtual public meeting and other
information can be found at <a href="https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022">https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022</a>.
You may submit written comments on the recommendations as follows.
Please note that late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before April 21, 2022. The
<a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of April 21, 2022.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2020-N-0907 for ``Medical Device User Fee Amendments; Public
Meeting.'' FDA published the commitment letter on March 22, 2022. The
commitment letter can be found in the docket and on this website at
<a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v">https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v</a>. The docket will close
on April 21, 2022. 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 available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Mimi Nguyen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5547, Silver Spring, MD 20993, 301-796-4125,
<a href="/cdn-cgi/l/email-protection#723f362734332420171307061a1d001b0813061b1d1c321416135c1a1a015c151d04"><span class="__cf_email__" data-cfemail="5d1019081b1c0b0f383c282935322f34273c293432331d3b393c7335352e733a322b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of proposed recommendations for
the reauthorization of MDUFA, which authorizes FDA to collect user fees
and use them for the process for the review of device applications. We
are also announcing a virtual public meeting to discuss such
recommendations. The current authorization of the MDUFA program
continues until September 30, 2022. Without new legislation, FDA will
no longer be able to collect user fees for future fiscal years to
provide funds for the process for the review of device applications.
Section 738A(b)(4) of the FD&C Act (21 U.S.C. 379j-1(b)(4))
requires that, after holding negotiations with regulated industry, we
take the following actions: (1) Present the recommendations to the
Committee on Energy and Commerce of the U.S. House of Representatives
and the Committee on Health, Education, Labor, and
[[Page 20438]]
Pensions of the U.S. Senate; (2) publish the recommendations in the
Federal Register; (3) provide a period of 30 days for the public to
submit written comments on the recommendations; (4) hold a meeting at
which the public may present its views on the recommendations; and (5)
after consideration of public views and comments, revise the
recommendations as necessary. This notice, the 30-day comment period,
and the public meeting will satisfy parts of these requirements. After
the public meeting, we will revise the recommendations as necessary. In
addition, the Agency will present the recommendations to the
Congressional committees.
The purpose of the meeting is for the public to present its views
on the proposed recommendations for the reauthorized program (MDUFA V).
The meeting format will include presentations by FDA and different
stakeholder interest groups (such as industry, patient and consumer
advocates, healthcare professionals, and scientific and academic
experts). The Agency will also provide an opportunity for other
interested individuals to make presentations at the meeting.
The following information is provided to help potential meeting
participants better understand the history and evolution of the medical
device user fee program and the current status of the proposed MDUFA V
recommendations.
II. What is MDUFA and what does it do?
MDUFA is the law that authorizes FDA to collect fees from device
companies that register their establishments, submit applications to
market devices, and make other types of device submissions. In the
years preceding enactment of the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), FDA's medical
device program suffered a long-term, significant loss of resources that
undermined the program's capacity and performance. MDUFMA was enacted
``in order to provide FDA with the resources necessary to better review
medical devices, to enact needed regulatory reforms so that medical
device manufacturers can bring their safe and effective devices to the
American people at an earlier point in time, and to ensure that
reprocessed medical devices are as safe and effective as original
devices.'' H.R. Rep. 107-728 at p. 21 (October 7, 2002). MDUFMA was
authorized for 5 years and contained two important features that relate
to reauthorization:
<bullet> User fees for the review of medical device premarket
applications, reports, supplements, and premarket notification
submissions provided additional resources to make FDA reviews more
timely, predictable, and transparent to applicants. User fees and other
appropriations for the medical device program helped FDA expand
available expertise, modernize its information management systems,
provide new review options, and provide more guidance to prospective
submitters. The ultimate goal was for FDA to clear or approve safe and
effective medical devices more rapidly and predictably, benefiting
applicants, the healthcare community, and most importantly, patients.
<bullet> Negotiated performance goals for many types of premarket
reviews provided FDA with benchmarks for measuring review improvements.
These quantifiable goals became more demanding each year and included
FDA decision goals and cycle goals (cycle goals refer to FDA actions
prior to a final action on a submission). Under MDUFMA, FDA also agreed
to several other commitments that did not have specific timeframes or
direct measures of performance, such as expanding the use of meetings
with industry, maintenance of current performance in review areas where
specific performance goals had not been identified, and publication of
additional guidance documents.
Medical device user fees and increased appropriations were viewed
by FDA, Congress, and industry stakeholders as essential to support
high-quality, timely medical device reviews, and other activities
critical to the device review program.
MDUFMA provided for--and reauthorizations have maintained--fee
discounts and waivers for qualifying small businesses. Small businesses
make up a large proportion of the medical device industry, and these
discounts and waivers helped reduce the financial impact of user fees
on this sector of the device industry, which plays an important role in
fostering innovation.
Since MDUFMA was first enacted in 2002, it has been reauthorized
three times through the Medical Device User Fee Amendments of 2007
(MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III),
and the Medical Device User Fee Amendments of 2017 (MDUFA IV). MDUFA IV
has been in effect since 2017 and will expire on September 30, 2022
(<a href="https://www.fda.gov/media/100848/download">https://www.fda.gov/media/100848/download</a>). The MDUFA IV agreement
enabled FDA to continue making progress on reducing review times and
bringing devices to patients more quickly, while also enabling FDA to
move forward in critical areas, including:
<bullet> Building a sustainable infrastructure for efficient,
consistent, transparent, and high-quality regulation of devices
throughout the total product lifecycle;
<bullet> Accessing and using real-world evidence in the regulatory
decision-making process;
<bullet> Advancing patient engagement and the regulatory science of
patient input;
<bullet> Advancing the smart oversight of digital health
technologies in ways that support innovation, balance innovation and
safety, and show promise as a potential blueprint for future regulatory
approaches to emerging technologies.
In terms of review goals, FDA's performance was strong during the
initial years of MDUFA IV (FY 2018 and FY2019), continuing to meet and
exceed performance goals and working to reduce the time for patients to
have access to safe, new, innovative devices. During this time, FDA
achieved all of our submission review goals, met 21 of 24 performance
enhancement goals, and FDA and industry met three of four shared
outcome goals. Starting in FY 2020, the strain from the pandemic, as
well as a workload that exceeded assumptions underlying the MDUFA IV
agreement, resulted in failure to meet certain MDUFA IV goals.
Preliminary performance data through September 30, 2021, including
completed and pending reviews, indicate that FDA has met (or has the
potential to meet) 13 of the 16 FY 2020 review goals and 9 of the 13 FY
2021 review goals for which FDA had a sufficient MDUFA cohort to
calculate performance. FDA also completed, on time, all eight
performance enhancement goals due in FY 2021. However, FDA's response
to the unprecedented COVID-19 public health emergency has impacted
FDA's MDUFA performance, resulting in three missed FY 2020 review goals
and four missed FY 2021 review goals. Information about FDA's
performance is available in the yearly and quarterly MDUFA performance
reports, which are online at: <a href="https://www.fda.gov/about-fda/user-fee-performance-reports/mdufa-performance-reports">https://www.fda.gov/about-fda/user-fee-performance-reports/mdufa-performance-reports</a> and <a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/mdufa-reports">https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/mdufa-reports</a>.
III. Proposed MDUFA V Recommendations
In preparing the proposed recommendations to Congress for MDUFA
reauthorization, FDA conducted discussions with the device
[[Page 20439]]
industry and consulted with stakeholders, as required by the FD&C Act.
The Agency began the MDUFA reauthorization process by publishing a
notice in the Federal Register requesting public input on the
reauthorization and announcing a public meeting that was held on
October 27, 2020. The meeting included presentations by FDA (which
complemented videos released ahead of the public meeting highlighting
FDA's efforts and accomplishments under the MDUFA IV agreement) and a
series of panels with representatives of different stakeholder groups,
including patient and consumer advocacy groups, regulated industry, and
healthcare professionals. The materials from the meeting, including a
transcript and webcast recording, can be found at <a href="https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-10272020">https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-10272020</a>.
From February 2021 through March 2022, FDA conducted negotiations
with representatives of the device industry: The Advanced Medical
Technology Association; the Medical Device Manufacturers Association;
the Medical Imaging and Technology Alliance; and the American Clinical
Laboratory Association. During its negotiations with industry, FDA also
held monthly consultations with representatives of patient and consumer
advocacy groups and other public stakeholders. Meeting minutes are
posted on FDA's website at: <a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v">https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v</a>.
The proposed recommendations for MDUFA V address many priorities
identified by industry and other stakeholders. While some of the
proposed recommendations are new, many either build on successful
enhancements or refine elements from the existing program. FDA posted
the full text of the proposed MDUFA V commitment letter at: <a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v">https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v</a>. Each significant new or
modified recommendation is briefly described below with reference to
the applicable section of the proposed commitment letter.
A. Shared Outcome Goals
FDA and representatives of the device industry believe that the
process improvements outlined in the proposed commitment letter, when
implemented by all parties as intended, should reduce the average Total
Time to Decision for premarket approval applications (PMAs), and
premarket notification (510(k)) submissions, provided that the total
funding of the device review program adheres to the assumptions
underlying the MDUFA V agreement. Reducing average Total Time to
Decision, as defined in the commitment letter, is an important aspect
of the user fee program, so that safe and effective devices reach
patients and healthcare professionals more quickly. FDA proposes, for
PMA and 510(k) submissions, with the performance improvement
adjustments described below, that the Total Time to Decision will reach
270 calendar days for original PMA and panel-track supplement
submissions and 108 calendar days for 510(k)s by FY 2027.
Additional details regarding the shared outcome goals can be found
in Sections I and III of the proposed commitment letter.
B. Pre-Submissions
MDUFA V provides additional resources for FDA to address the
increasing volume of Pre-Submissions requests and to improve the Pre-
submission performance goal. FDA proposes to ramp up to a performance
goal of providing written feedback on at least 90 percent of Pre-
Submissions within 70 days or 5 calendar days prior to the scheduled
meeting, whichever comes sooner, by FY 2025. With the performance
improvement adjustments described below, FDA may continue to improve
this performance goal in FY 2026-2027. FDA will also update guidance to
include additional information to assist applicants and review staff in
identifying the circumstances in which an applicant's question is most
appropriate for informal communication instead of a Pre-Submission.
Additional details regarding Pre-Submissions can be found in Sections
II.A and III.C of the proposed commitment letter.
C. De Novo Requests
FDA will have an opportunity, with the performance improvement
adjustments described below, to ramp up to a De Novo decision goal of
90 percent of De Novo request submissions within 150 days in FY 2027.
Additional details regarding De Novo requests can be found in Sections
II.E and III.B of the proposed commitment letter.
D. Opportunity for Performance Improvements
FDA proposes adding a new performance improvement adjustment for
MDUFA V that would allow FDA to collect fees in addition to annual
total revenue in FY 2025, FY 2026, and/or FY 2027, if certain review
performance and/or shared outcome goals are met for FY 2023, 2024, and/
or 2025. If applicable, these fee increases will apply solely to
establishment registration fees and support improvements to the 510(k)
and PMA Shared Outcome Total Time to Decision goals, the Pre-Submission
Written Feedback goal, and the De Novo decision goal. The following
examples describe adjustments if goals are met for FY 2023:
<bullet> If FDA's 510(k) decision goal, the FDA/Industry 510(k)
Shared Outcome Total Time to Decision goal, FDA's PMA decision goal,
and the FDA/Industry PMA Shared Outcome Total Time to Decision goal are
met for FY 2023, and fee revenue above the annual total revenue amount
is provided in FYs 2026 and 2027, then the 510(k) Shared Outcome Total
Time to Decision goal and the PMA Shared Outcome Total Time to Decision
goal will be adjusted. Specifically, the 510(k) Shared Outcome Total
Time to Decision goal will be improved to 108 days for FYs 2026 and
2027, and the PMA Shared Outcome Total Time to Decision goal will be
improved to 275 days for FYs 2026 and 2027.
<bullet> If the Pre-Submission Written Feedback goal is met for FY
2023, and fee revenue above the annual total revenue amount is provided
to support performance improvements in FYs 2025, 2026, and 2027, the
maximum number of Pre-Submissions subject to the goal will improve to
4,700 Pre-Submissions in FYs 2025, 2026, and 2027.
<bullet> If the De Novo decision goal is met for FY 2023, and fee
revenue above the annual total revenue amount is provided in FYs 2026
and 2027 to support performance improvements, the goal will improve to
80 percent of De Novo requests receiving a MDUFA decision within 150
FDA days for FYs 2026 and 2027.
Additional details regarding the opportunity for performance
improvements can be found in Section III of the proposed commitment
letter. Under the new performance improvement adjustment, FDA may
receive additional funding up to the following maximum amounts (which
would be adjusted for inflation):
<bullet> $15,396,600 for FY 2025
<bullet> $44,135,700 for FY 2026
<bullet> $56,244,000 for FY 2027
E. Deficiency Letters
To support improved communication in FDA letters requesting
additional
[[Page 20440]]
information, FDA will clarify what constitutes a statement of the basis
for the deficiency in updated guidance, train staff and managers on the
updated guidance, and establish a performance goal for providing a
statement of the basis for the deficiency that ramps up to 95 percent
by FY 2027.
F. Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot
FDA will launch a voluntary pilot program to provide more frequent
and timely interactions for industry and other stakeholders earlier in
the device development process with a focus on Breakthrough (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program</a>) and Safer Technologies Program devices
(<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices</a>). Through the TAP
Pilot, FDA will provide strategic engagement for innovative devices of
public health importance by facilitating improved strategic decision
making during product development, including earlier identification,
assessment, and mitigation of product-development risk. The TAP Pilot
will also support engagement to better align expectations regarding
evidence generation, improve submission quality, and improve the
efficiency of the premarket review process. Additional details
regarding the TAP Pilot can be found in Section V.J of the proposed
commitment letter.
G. Patient Science and Engagement
FDA proposes to continue building the Patient Science and
Engagement program, which engages patients and supports incorporating
their perspectives in the regulatory process. In particular, FDA
proposes to expand the program through the following activities:
Facilitate patient engagement through patient-friendly educational
content; explore ways to advance health equity; continue to expand
patient science review expertise and capacity; improve the regulatory
predictability and impact of patient science, including shared
examples; hold a public meeting on patient-generated health data for
collecting clinical outcome assessment (COA) data and for remote
clinical trials; and issue draft guidance on incorporating COA into
premarket studies and update patient preference information guidance.
Additional details regarding patient science and engagement can be
found in Section V.E of the proposed commitment letter.
H. Enhanced Use of Consensus Standards
During MDUFA IV, FDA initiated the voluntary Accreditation Scheme
for Conformity Assessment (ASCA) pilot to enhance product reviewers'
and device manufacturers' confidence in medical device testing when
manufacturers rely on testing completed by ASCA-accredited testing
laboratories. FDA proposes to use lessons learned from implementation
of the ASCA pilot in MDUFA IV to transition to a sustainable and
expanded program in MDUFA V. Additional details regarding the enhanced
use of consensus standards can be found in Section V.C of the proposed
commitment letter.
I. International Harmonization
FDA will enhance international harmonization activities by
expanding engagement in international harmonization and convergence
efforts to promote alignment with international best practices and
internationally developed policies. Additional details regarding
international harmonization can be found in Section V.I of the proposed
commitment letter.
J. Third Party Premarket Review Program
FDA proposes to maintain the Accredited Persons (Third Party
Review) program in MDUFA V. Additional details regarding the Third
Party Review program can be found in Section V.D of the proposed
commitment letter.
K. Real World Evidence (RWE)
FDA proposes to continue to advance the development of Real-World
Data (RWD) and RWE methods and policies to advance regulatory
acceptance for premarket submissions. Additional details regarding RWE
can be found in Section V.F of the proposed commitment letter.
L. Digital Health
FDA proposes to continue building its digital health expertise,
working to streamline and align FDA review processes with software
lifecycles for digital health products, engaging in international
harmonization efforts related to software review, and conducting other
activities related to digital health. Additional details regarding
digital health can be found in Section V.G of the proposed commitment
letter.
M. Information Technology (IT)
FDA proposes to continue to enhance IT infrastructure to support
the process for the review of device applications, including improving
a submission progress tracking system and developing electronic
submission templates for more submission types. Additional details
regarding IT can be found in Section IV.C of the proposed commitment
letter.
N. Financial Transparency and Hiring
FDA proposes to take several new steps to provide additional
transparency and accountability measures with respect to MDUFA V
finances and hiring. The Agency proposes to publish a MDUFA 5-year
financial plan that will be updated annually. In addition, new
statutory language for an operating reserve adjustment is proposed to
reflect FDA and industry-agreed measures for managing the amount of
operating reserves in the MDUFA carryover balance. Under this new
provision, FDA would decrease registration fees if the amount of
operating reserves exceeds the designated amount. The designated amount
for a fiscal year is equal to 13 weeks of operating reserves plus the 1
month of operating reserves required by statute. Further, the amount of
carryover user fees intended to support the Third Party Review program
and TAP Pilot during MDUFA V would be excluded for the period of FY
2023 through FY 2026 when calculating the amount of operating reserves
to determine if registration fees will be decreased. User fee funds in
the carryover balance that are considered unappropriated or unearned
are not included in the operating reserves.
To help ensure that FDA accomplishes hiring in accordance with the
assumptions underlying the MDUFA V agreement, FDA proposes to set
annual hiring goals for MDUFA V positions. Proposed statutory language
would provide for the reduction of establishment registration fees for
FYs 2025, 2026, and 2027, if the Agency does not meet those goals for
FYs 2023, 2024, and 2025, respectively, by a certain threshold. The
amount of the hiring adjustment fee decrease would be the product of
the number of hires by which the hiring goal was missed and one-quarter
of the inflation-adjusted cost per full time equivalent. Additional
details regarding financial transparency and hiring can be found in
Section IV.B of the proposed commitment letter.
O. Independent Assessments
FDA and industry propose to participate in a targeted assessment of
the management of the process for the review of device applications.
FDA also proposes to retain an independent contractor with expertise in
assessing public sector workforce data analysis
[[Page 20441]]
and reporting to conduct an assessment of current methodologies and
data/metrics available to represent the MDUFA workforce. Additional
details regarding the independent assessments can be found in Section
VI of the proposed commitment letter.
P. Performance Reports
FDA proposes to continue to report quarterly and annually on
performance against commitments. Additionally, FDA proposes to report
quarterly on progress toward hiring goals and funding intended for RWE
activities. FDA will report annually on the primary cost drivers for
changes to personnel compensation and benefits costs. Additional
details regarding performance reporting can be found in Section VII of
the proposed commitment letter.
Q. User Fee Revenue and Fee Allocations
As part of MDUFA V, FDA and industry propose updating the base fee
amounts for PMAs and annual establishment registrations, as well as the
annual total revenue amounts, to reflect negotiated fee levels. The
statutory total revenue amounts, base fee amounts, and amounts for
potential performance improvement adjustments are proposed in FY 2021
dollars, such that annual inflation adjustments will be used to inflate
FY 2021 dollars to the appropriate amounts for each fiscal year in
MDUFA V. FDA and industry also propose to change the fee for a PMA
Panel-Track supplement from 75 percent to 80 percent of the fee for an
original PMA and to change the fee for a 510(k) submission from 3.4
percent to 4.5 percent of the fee for a PMA. Finally, a minor change is
proposed to the statutory provisions regarding fee waivers and
reductions for small businesses to clarify that an applicant seeking a
waiver or reduction is not required to submit a certification from the
national taxing authority of the foreign country in which the
applicant, or its affiliate, is located, if the country has no national
taxing authority.
FDA will post the agenda approximately 5 days before the meeting
at: <a href="https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022">https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022</a>.
IV. Participating in the Public Meeting
Registration: To register for the public meeting, please visit
<a href="https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022">https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022</a>. Please provide complete contact information
for each attendee, including name, title, affiliation, email, and
telephone number. Registrants will receive confirmation after they have
been accepted.
Registration is free. Persons interested in attending by webcast
the MDUFA virtual public meeting must register online by 4 p.m. Eastern
Time, April 18, 2022. Early registration is recommended.
If you need special accommodations because of a disability, please
contact Susan Monahan at 240-205-2260 or <a href="/cdn-cgi/l/email-protection#21725452404f0f6c4e4f4049404f614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="cc9fb9bfada2e281a3a2ada4ada28caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a> no
later than April 11, 2022.
Requests for Oral Presentations: This meeting includes a public
comment session and topic-focused sessions. During online registration
you may indicate if you wish to present during the public comment
session or a specific session, and which topic(s) you wish to address.
All requests to make oral presentations virtually by webcast must be
received by April 11, 2022, at 4 p.m. Eastern Time. FDA will do its
best to accommodate requests to make public comments. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations and request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin
and will notify speakers by April 12, 2022. If selected for
presentation, any presentation materials must be emailed to Mimi Nguyen
(see FOR FURTHER INFORMATION CONTACT) no later than April 13, 2022, at
4 p.m.. Eastern Time. No commercial or promotional material will be
permitted to be presented or distributed at the meeting.
FDA is holding this meeting to provide information on the proposed
recommendations for the reauthorization of MDUFA for FYs 2023 through
2027. To permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the meeting topics. The docket was opened on March 22, 2022.
The proposed commitment letter was posted in the docket and on this
website at: <a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v">https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v</a>. The
docket will close on April 21, 2022, 30 days after the proposed
commitment letter was posted.
Streaming Webcast of the Public Meeting: The webcast link will be
available on the registration web page after April 11, 2022.
Organizations are requested to register all participants.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available
approximately 45 days after the public workshop on the internet at:
<a href="https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022">https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-04192022</a>.
Dated: April 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07451 Filed 4-6-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 7, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.