[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Pages 46956-46958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19290]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0223]
Humanitarian Device Exemption Program; Guidance for Industry and
Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Humanitarian Device
Exemption Program.'' This guidance concerns the humanitarian device
exemption (HDE) program as a whole and, among other topics, it explains
the criteria FDA considers to determine if ``probable benefit'' has
been demonstrated as part of the Agency's
[[Page 46957]]
decision-making process regarding marketing authorization for a
humanitarian use device (HUD). The guidance also reflects recent
amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that
affect the HDE program and answers common questions that we receive
about the program.
DATES: The announcement of the guidance is published in the Federal
Register on September 6, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2014-D-0223 for ``Humanitarian Device Exemption Program.'' Received
comments 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 between 9 a.m.
and 4 p.m., Monday through Friday.
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.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Humanitarian Device Exemption Program'' to the Office of Policy,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research (CBER), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA developed this guidance to clarify to industry and FDA staff
the current review practices for the HDE program. This guidance answers
common questions about the HDE program and responds to a requirement in
the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) to define the
criteria for establishing ``probable benefit'' as that term is used in
section 520(m)(2)(C) of the FD&C Act (21 U.S.C. 360j(m)(2)(C)).
This guidance reflects recent amendments to the FD&C Act that
affect the HDE program. Specifically, section 3052 of the Cures Act
modified the eligibility for an HDE by increasing the threshold number
of patients affected by the disease or condition that a HUD is designed
to treat or diagnose to ``not more than 8,000 individuals in the United
States.'' Further, section 3056 of the Cures Act removed the
requirement that institutional review committees, i.e., institutional
review boards (IRBs), that supervise the clinical testing of HUDs or
approve the use of HUDs in clinical care, be local. Additionally, the
FDA Reauthorization Act of 2017 (Pub. L. 115-52) amended section 520(m)
of the FD&C Act to provide that the use of a device under an HDE at a
facility to treat or diagnose patients may be approved by an IRB or an
appropriate local committee. Previously, section 520(m)(4) of the FD&C
Act only allowed an IRB to perform this function.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of June 13, 2018 (83 FR 27614). FDA
revised the guidance as appropriate in response to
[[Page 46958]]
the comments. This guidance supersedes ``Guidance for HDE Holders,
Institutional Review Boards (IRBs), Clinical Investigators, and Food
and Drug Administration Staff; Humanitarian Device Exemption (HDE)
Regulation: Questions and Answers,'' issued July 8, 2010 (available at:
https://www.fda.gov/media/74307/download).
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the Humanitarian Device Exemption Program.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Humanitarian Device Exemption
Program'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number 17040 and complete title of the guidance in the request.
IV. Paperwork Reduction Act of 1995
This guidance 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. 3501-3520). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
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21 CFR part, guidance, or FD&C OMB control
Act section Topic No.
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807, 812, 814.................. Acceptance of Data from 0910-0741
Clinical
Investigations for
Medical Devices.
814............................ Pediatric Uses of 0910-0748
Devices.
814, subparts A through E...... Premarket Approval..... 0910-0231
814, subpart H................. Humanitarian Device 0910-0332
Exemption.
812............................ Investigational Device 0910-0078
Exemption.
``De Novo Classification De Novo classification 0910-0844
Process (Evaluation of process.
Automatic Class III
Designation)''.
803............................ Medical Devices; 0910-0437
Medical Device
Reporting;
Manufacturer
Reporting, Importer
Reporting, User
Facility Reporting,
Distributor Reporting.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
520(m) of the FD&C Act......... Humanitarian Device 0910-0661
Exemption Applications
and Annual
Distribution Number
Reporting Requirements.
50, 56......................... Protection of Human 0910-0755
Subjects: Informed
Consent; Institutional
Review Boards.
56............................. Institutional Review 0910-0130
Boards.
10............................. Administrative 0910-0191
Practices and
Procedures.
54............................. Financial Disclosure by 0910-0396
Clinical Investigators.
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Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19290 Filed 9-5-19; 8:45 am]
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