Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
| Published date | 07 February 2020 |
| Record Number | 2020-02481 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 26 (Friday, February 7, 2020)
[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7311-7313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02481]
[[Page 7311]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0825]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket Approval of
Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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 March
9, 2020.
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 0910-0231.
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.
Premarket Approval of Medical Devices
OMB Control Number 0910-0231--Extension
Under section 515 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360e) all devices placed into class III by FDA are
subject to premarket approval application (PMA) requirements. PMA is
the process of scientific and regulatory review to ensure the safety
and effectiveness of class III devices. An approved PMA is, in effect,
a private license granted to the applicant for marketing a particular
medical device. A class III device that fails to meet PMA requirements
is considered to be adulterated under section 501(f) of the FD&C Act
(21 U.S.C. 351(f)) and cannot be marketed. PMA requirements apply
differently to preamendments devices, postamendments devices, and
transitional class III devices.
Manufacturers of class III preamendments devices (devices that were
in commercial distribution before May 28, 1976) are not required to
submit a PMA until 30 months after the issuance of a final
classification regulation or until 90 days after the publication of a
final regulation requiring the submission of a PMA, whichever period is
later. FDA may allow more than 90 days after issuance of a final rule
for submission of a PMA.
A postamendments device is one that was first distributed
commercially on or after May 28, 1976. Postamendments devices
determined by FDA to be substantially equivalent to preamendments class
III devices are subject to the same requirements as the preamendments
devices. FDA determines substantial equivalence after reviewing an
applicant's premarket notification submitted in accordance with section
510(k) of the FD&C Act. Postamendments devices determined by FDA to be
not substantially equivalent to either preamendments devices or
postamendments devices classified into class I or II are ``new''
devices and fall automatically into class III. Before such devices can
be marketed, they must have an approved PMA or must be reclassified
into class I or class II.
The Food and Drug Administration Modernization Act of 1997 (FDAMA)
(Pub. L. 105-115) amended the FD&C Act by streamlining the process of
bringing safe and effective drugs, medical devices, and other therapies
to the U.S. market. FDAMA added section 515(d)(6) to the FD&C Act,
which provided that PMA supplements were required for all device
changes that affect safety and effectiveness unless such changes are
modifications to manufacturing procedures or method of manufacture.
That type of manufacturing change requires a 30-day notice, or where
FDA finds such notice inadequate, a 135-day PMA supplement.
The implementing regulations, contained in 21 CFR part 814, further
specify the contents of a PMA for a medical device and the criteria FDA
will employ in approving, denying, or withdrawing approval of a PMA and
supplements to PMAs. The regulations' purpose is to establish an
efficient and thorough procedure for FDA's review of PMAs and
supplements to PMAs for class III medical devices. The regulations
facilitate the approval of PMAs and supplements to PMAs for devices
that have been shown to be reasonably safe and effective and otherwise
meet the statutory criteria for approval. The regulations also allow
for the denial of PMAs and supplements to PMAs for devices that have
not been shown to be reasonably safe and effective and that do not
otherwise meet the statutory criteria for approval.
The burden estimate is based on the annual rate of receipt of PMA
submissions for fiscal years (FYs) 2016 through 2018 and our
expectation of submissions to come in the next few years. The burden
data for PMAs is based on data provided by applicants by device type
and cost element in an earlier study.
Reporting Burden
Section 814.15(b)--Research Conducted Outside the United States.
FDA will accept information on a clinical investigation conducted
outside the United States (OUS) to support a PMA if the investigation
is well-designed and well-conducted and certain other conditions are
met, including that the investigation was conducted in accordance with
good clinical practice (GCP) as specified in 21 CFR 812.28. If the OUS
clinical investigation did not conform to GCP, then the PMA submission
should include a waiver request or a statement explaining the reason
for not conducting the investigation in accordance with GCP and a
description of steps taken to ensure that the data and results are
credible and accurate and that the rights, safety, and well-being of
subjects have been adequately protected. Based on the number of PMAs
received that contained studies from overseas, FDA estimates that the
burden estimate necessary to meet this requirement is 50 hours.
Section 814.20--Application. Specifies the information required in
a PMA and update reports such as the applicant's name and address, a
description of the device, its labeling, its indications for use, and
summary of clinical and non-clinical studies. Included in this
requirement is the conduct of laboratory and clinical trials, as well
as the analysis, review, and physical preparation of the PMA
application. FDA estimates that 38 applicants, including hospital
remanufacturers of single-use devices, will be affected by these
requirements, which are based on the actual average of FDA receipt of
new PMA applications in FYs 2016 through 2018.
Additionally, the ``Human Subject Protection; Acceptance of Data
from
[[Page 7312]]
Clinical Investigations for Medical Devices'' final rule (83 FR 7366;
February 21, 2018) amended this section to address requirements for a
PMA supported by data from clinical investigations conducted outside
the United States. The applicant will be required to submit the
information as described in Sec. 814.20(b)(6)(ii)(C). We estimate this
will take 30 minutes per respondent. We estimate that 10 respondents
annually will submit such information.
The collections in OMB control number 0910-0741, ``Human Subject
Protection; Acceptance of Data from Clinical Studies for Medical
Devices,'' were submitted to OMB as a new information collection
request with the expectation that the currently approved requirements
will be amended. As noted in the Supporting Statement for OMB control
number 0910-0741, we are amending OMB control number 0910-0231 to
reflect the information collections associated with the rulemaking
under Sec. 814.20(b)(6)(ii)(C).
Section 814.37(a) through (c) and (e)--PMA Amendments and
Resubmitted PMAs. As part of the review process, FDA often requests the
PMA applicant to submit additional information regarding the device
necessary for FDA to file the PMA or to complete its review and make a
final decision. The PMA applicant may, on their own initiative, submit
additional information to FDA during the review process. These
amendments contain information ranging from additional test results and
reanalysis of the original data set to revised device labeling. Almost
all PMAs received by the Agency have amendments submitted during the
review process.
Section 814.39(a)--PMA Supplements. This information collection
includes the requirements for the range of PMA supplements (panel
track, 180-day fee-based, 180-day non-fee-based, and real-time
supplements).
Section 814.39(d)--Special PMA Supplements--Changes Being Affected.
This type of supplement is intended to enhance the safety of the device
or the safe use of the device. The number of PMA supplements received
that fit this category averaged 75 per year based on the numbers
received from FYs 2016 through 2018.
Section 814.39(f)--30-Day Notice. Under section 515(d) of the FD&C
Act, modifications to manufacturing procedures or methods of
manufacture that affect the safety and effectiveness of a device
subject to an approved PMA do not require submission of a PMA
supplement under paragraph (a) of that section and are eligible to be
the subject of a 30-day notice. A 30-day notice shall describe in
detail the change, summarize the data or information supporting the
change, and state that the change has been made in accordance with the
requirements of part 820 (21 CFR part 820). The applicant may
distribute the device 30 days after the date on which FDA receives the
30-day notice, unless FDA notifies the applicant within 30 days from
receipt of the notice that it is not adequate.
Section 814.82(a)(9)--Postapproval Requirements. Postapproval
requirements concern approved PMAs that were not reclassified and
require a periodic report. After approval, all PMAs require a
submission of an annual report. A majority of the submitted PMAs
require associated postapproval studies, i.e., followup of patients
used in clinical trials to support the PMA or additional preclinical
information that is labor-intensive to compile and complete; the
remaining PMAs require minimal information.
Section 814.84(b)--Periodic Reports. Postapproval requirements
described in Sec. 814.82(a)(7) require submission of an annual report
for each approved PMA. FDA estimates that respondents will average
about 10 hours in preparing their reports to meet this requirement.
This estimate is based on FDA's experience and consultation with
industry.
The Breakthrough Devices Program--The Breakthrough Devices Program
supersedes the Expedited Access Pathway and Priority Review for medical
devices. The guidance document ``Breakthrough Devices Program''
implements section 515B of the FD&C Act (21 U.S.C. 360e-3), as created
by section 3051 of the 21st Century Cures Act (Pub. L. 114-255) and
amended by section 901 of the FDA Reauthorization Act of 2017 (Pub. L.
115-52). The Breakthrough Devices Program is a voluntary program for
certain medical devices and device-led combination products that
provide for more effective treatment or diagnosis of life-threatening
or irreversibly debilitating diseases or conditions. The program is
intended to help patients have more timely access to these medical
devices by expediting their development, assessment, and review, while
preserving the statutory standards for premarket approval, 510(k)
clearance, and De Novo marketing authorization, consistent with the
Agency's mission to protect and promote public health.
Section 520(g)(7) of the FD&C Act (21 U.S.C. 360j(g)(7))--Agreement
Meeting. Applicants planning to submit a PMA may submit a written
request to reach agreement with FDA on the key parameters of the
investigational plan.
Section 513(a)(3)(D) of the FD&C Act (21 U.S.C. 360c(a)(3)(D))--
Determination Meeting. Applicants planning to submit a PMA may submit a
written request to FDA for a meeting to determine the type of
information (valid scientific evidence) necessary to support the
effectiveness of their device.
Section 515(c)(3) of the FD&C Act--Panel of Experts. An original
PMA or panel track PMA supplement is taken to an advisory panel of
experts unless FDA determines that the information in the application
substantially duplicates information that has previously been reviewed
by the panel.
Section 515(d)(3) of the FD&C Act--Day 100 Meeting. FDA must, upon
the written request of the applicant, meet with that party within 100
days of receipt of the filed PMA application to discuss the review
status of the application. With the concurrence of the applicant, a
different schedule may be established. Prior to this meeting, FDA must
inform the applicant in writing of any identified deficiencies and what
information is required to correct those deficiencies. FDA must also
promptly notify the applicant if FDA identifies additional deficiencies
or of any additional information required to complete Agency review.
Recordkeeping
Section 814.82(a)(5) and (6)--Maintenance of Records. The
recordkeeping burden under this section requires the maintenance of
records used to trace patients, and the organization and indexing of
records into identifiable files to ensure the device's continued safety
and effectiveness. These records are required of all applicants who
have an approved PMA.
PMAs have been required since 1976, and there are 801 active PMAs
that could be subject to these requirements, based on actual FDA data,
and approximately 39 new PMAs are approved every year. The aggregate
burden for the estimated 446 PMA holders of approved original PMAs for
the next few years is estimated to be 7,582 hours.
The applicant determines which records should be maintained during
product development to document and/or substantiate the device's safety
and effectiveness. Records required by the current good manufacturing
practices for medical devices regulation (part 820) may be relevant to
a PMA review and may be submitted as part of an application. In
individual instances, records may be required as conditions of
[[Page 7313]]
approval to ensure the device's continuing safety and effectiveness.
In the Federal Register of October 24, 2019 (84 FR 57030), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity/21 CFR or FD&C Act Number of responses per Total annual Average burden Total hours
section respondents respondent responses per response
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Research conducted outside 25 1 25 2 50
the United States
(814.15(b)).................
PMA application (814.20)..... 46 1 46 668 30,728
Information on clinical 10 1 10 0.5 (30 minutes) 5
investigations conducted
outside the United States
(814.20(b)(6)(ii)(C)).......
PMA amendments and 1,528 1 1,528 167 255,176
resubmitted PMAs (814.37(a)-
(c) and (e))................
PMA supplements (814.39(a)).. 777 1 777 60 46,620
Special PMA supplement-- 75 1 75 6 450
changes being affected
(814.39(d)).................
30-day notice (814.39(f)).... 1,722 1 1,722 16 27,552
Postapproval requirements 121 1 121 135 16,335
(814.82(a)(9))..............
Periodic reports (814.84(b)). 764 1 764 10 7,640
Agreement meeting (520(g)(7)) 1 1 1 50 50
Breakthrough Devices Program 11 1 11 10 110
(515(B) of the FD&C Act)....
Determination Meeting 1 1 1 50 50
(513(1)(3)(D) of the FD&C
Act)........................
Panel meeting (515(c)(3) of 1 1 1 30 30
the FD&C Act)...............
Day 100 meeting (515(d)(3) of 14 1 14 10 140
the FD&C Act)...............
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Total.................... .............. .............. .............. ................. 384,936
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Maintenance of records (814.82(a)(5) and (6))...................... 446 1 446 17 7,582
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We made the following changes to the information collection:
Added the burden estimate for ``Information on clinical
investigations conducted outside the United States (Sec.
814.20(b)(6)(ii)(C)),'' which is associated with the ``Human Subject
Protection; Acceptance of Data from Clinical Investigations for Medical
Devices'' final rule as described previously in this document.
Revised the burden description and table to reflect that
the Expedited Access Pathway and Priority Review have been superseded
by the Breakthrough Devices Program.
Updated our burden estimate with FYs 2016 through 2018
data.
These adjustments resulted in an overall increase of 34,782 hours
to the estimated burden.
Dated: January 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02481 Filed 2-6-20; 8:45 am]
BILLING CODE 4164-01-P
