[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Pages 53448-53450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0477]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Investigational 
Device Exemptions Reports and Records

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 
November 6, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0078. 
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.m.-12p.m., 
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.

Investigational Device Exemptions Reports and Records

OMB Control Number 0910-0078--Extension

    Section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360j(g)) establishes the statutory authority to collect 
information regarding investigational devices and establishes rules 
under which new medical devices may be tested using human subjects in a 
clinical setting. The Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-

[[Page 53449]]

115) added section 520(g)(6) to the FD&C Act and permitted changes to 
be made to either the investigational device or to the clinical 
protocol without FDA approval of an investigational device exemption 
(IDE) supplement. An IDE allows a device, which would otherwise be 
subject to provisions of the FD&C Act, such as premarket notification 
or premarket approval, to be used in investigations involving human 
subjects in which the safety and effectiveness of the device is being 
studied. The purpose of part 812 (21 CFR part 812) is to encourage, to 
the extent consistent with the protection of public health and safety 
and with ethical standards, the discovery and development of useful 
devices intended for human use. The IDE regulation is designed to 
encourage the development of useful medical devices and allow 
investigators the maximum freedom possible, without jeopardizing the 
health and safety of the public or violating ethical standards. To do 
this, the regulation provides for different levels of regulatory 
control, depending on the level of potential risk the investigational 
device presents to human subjects.
    Investigations of significant risk devices, ones that present a 
potential for serious harm to the rights, safety, or welfare of human 
subjects, are subject to the full requirements of the IDE regulation. 
Nonsignificant risk device investigations, i.e., devices that do not 
present a potential for serious harm, are subject to the reduced burden 
of the abbreviated requirements. The regulation also includes 
provisions for treatment IDEs. The purpose of these provisions is to 
facilitate the availability, as early in the device development process 
as possible, of promising new devices to patients with life-threatening 
or serious conditions for which no comparable or satisfactory 
alternative therapy is available. Section 812.10 permits the sponsor of 
the IDE to request a waiver of any of the requirements of part 812. 
Sections 812.20, 812.25, and 812.27 describe the information necessary 
to file an IDE application with FDA. The submission of an IDE 
application to FDA is required only for significant risk device 
investigations. Section 812.20 lists the data requirements for the 
original IDE application, Sec.  812.25 lists the contents of the 
investigational plan, and Sec.  812.27 lists the data relating to 
previous investigations or testing. The information in the original IDE 
application is evaluated by the Center for Devices and Radiological 
Health to determine whether the proposed investigation will reasonably 
protect the public health and safety.
    Upon approval of an IDE application by FDA, a sponsor must submit 
certain requests and reports. Under Sec.  812.35, a sponsor who wishes 
to make a change in the investigation that affects the scientific 
soundness of the study or the rights, safety, or welfare of the 
subjects, is required to submit a request for the change to FDA. 
Section 812.150 requires a sponsor to submit reports to FDA. These 
requests and reports are submitted to FDA as supplemental applications. 
This information is needed for FDA to assure protection of human 
subjects and to allow review of the study's progress. Section 812.36(c) 
identifies the information necessary to file a treatment IDE 
application. FDA uses this information to determine if wider 
distribution of the device is in the interest of the public health. 
Section 812.36(f) identifies the reports required to allow FDA to 
monitor the size and scope of the treatment IDE, to assess the 
sponsor's due diligence in obtaining marketing clearance of the device, 
and to ensure the integrity of the controlled clinical trials.
    Section 812.140 lists the recordkeeping requirements for 
investigators and sponsors. FDA requires this information for tracking 
and oversight purposes. Investigators are required to maintain records, 
including correspondence and reports concerning the study, records of 
receipt, use or disposition of devices, records of each subject's case 
history and exposure to the device, informed consent documentation, 
study protocol, and documentation of any deviation from the protocol. 
Sponsors are required to maintain records including correspondence and 
reports concerning the study, records of shipment and disposition, 
signed investigator agreements, adverse device effects information, 
and, for a nonsignificant risk device study, an explanation of the 
nonsignificant risk determination, records of device name and intended 
use, study objectives, investigator information, investigational review 
board information, and statement on the extent that good manufacturing 
practices will be followed.
    For a nonsignificant risk device investigation, the investigators' 
and sponsors' recordkeeping and reporting burden is reduced. Pertinent 
records on the study must be maintained by both parties, and reports 
are made to sponsors and institutional review boards (IRBs). Reports 
are made to FDA only in certain circumstances, e.g., recall of the 
device, the occurrence of unanticipated adverse effects, and as a 
consequence of certain IRB actions.
    In the Federal Register of June 11, 2019 (84 FR 27139), 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 section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Waivers--812.10.................               1               1               1               1               1
IDE Application--812.20, 812.25,             229               1             229              80          18,320
 and 812.27.....................
Supplements--812.35 and 812.150.             654               5           3,270               6          19,620
Treatment IDE Applications--                   1               1               1             120             120
 812.36(c)......................
Treatment IDE Reporting--                      1               1               1              20              20
 812.36(f)......................
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    Total.......................  ..............  ..............  ..............  ..............          38,081
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 53450]]


                               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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Original--812.140...............             229               1             229              10           2,290
Supplemental--812.140...........             654               5           3,270               1           3,270
Nonsignificant--812.140.........             356               1             356               6           2,136
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    Total.......................  ..............  ..............  ..............  ..............           7,696
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                      Activity/21 CFR section                           Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Reports for Nonsignificant Risk Studies--812.150...................               1                1                1                6                6
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall decrease of 528 hours. We attribute this adjustment to a 
decrease in the number of submissions we received over the last few 
years.

    Dated: September 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21785 Filed 10-4-19; 8:45 am]
 BILLING CODE 4164-01-P