Document ID: FDA-2014-D-0223-0021
Agency: fda
Document Type: Notice
Title: Humanitarian Device Exemption Program; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2019-09-06T04:00Z

[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 CDRH-Guidance@fda.hhs.gov 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:

------------------------------------------------------------------------
 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]
 BILLING CODE 4164-01-P