83 FR 27614 - Humanitarian Device Exemption Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 114 (June 13, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Humanitarian Device Exemption (HDE) Program.'' This draft guidance concerns the HDE program as a whole and, among other topics, it explains the criteria FDA considers to determine if ``probable benefit'' has been demonstrated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 decision-making process regarding marketing authorization for a humanitarian use device (HUD). The draft guidance also incorporates recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that affect the HDE program and answers other common questions that we receive about the program. This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27614-27616]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12633]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0223]


Humanitarian Device Exemption Program; Draft Guidance for 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the availability of the draft guidance entitled ``Humanitarian Device 
Exemption (HDE) Program.'' This draft guidance concerns the HDE program 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 decision-making process regarding marketing 
authorization for a humanitarian use device (HUD). The draft guidance 
also incorporates recent amendments to the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) that affect the HDE program and answers other 
common questions that we receive about the program. This draft guidance 
is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by August 13, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.

[[Page 27615]]

     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 (HDE) 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.thefederalregister.org/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 draft guidance document entitled 
``Humanitarian Device Exemption (HDE) Program'' to the Office of the 
Center Director, Guidance and Policy Development, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, 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 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA developed this draft guidance to clarify to industry and FDA 
staff the current review practices for the HDE program. This draft 
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 draft guidance incorporates 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 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 is providing an interpretation of the term ``appropriate 
local committee'' in this draft guidance, and we welcome comment on the 
characteristics that should define an appropriate local committee for 
purposes of the HDE program.
    This draft guidance supplants the draft guidance, ``Humanitarian 
Device Exemption (HDE): Questions and Answers--Draft Guidance for HDE 
Holders, IRBs, Clinical Investigators, and Food and Drug Administration 
Staff,'' issued on March 18, 2014. When final, this guidance will 
supersede the guidance, ``Guidance for HDE holders, IRBs, Clinical 
Investigators, and Food and Drug Administration Staff, HDE Regulation: 
Questions and Answers,'' issued on July 8, 2010, available online at: 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM110203.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 draft guidance may do 
so by

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downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Humanitarian Device Exemption (HDE) Program'' 
may send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 17040 
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance. 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 21 CFR part 10 have been 
approved under OMB control number 0910-0191; the collections of 
information in 21 CFR parts 50 and 56 have been approved under OMB 
control numbers 0910-0755 and 0910-0130; the collections of information 
in 21 CFR part 54 have been approved under OMB control number 0910-
0396; the collections of information in 21 CFR part 803 have been 
approved under OMB control number 0910-0437; the collections of 
information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the collections of information in 21 CFR part 814, 
subparts A through E, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 814, subpart H, 
have been approved under OMB control number 0910-0332; the collections 
of information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; the collections of information regarding Information 
to Accompany HDE Applications and Annual Distribution Number Reporting 
Requirements have been approved under OMB control number 0910-0661; and 
the collections of information in the guidance document ``De Novo 
Classification Process (Evaluation of Automatic Class III 
Designation)'' have been approved under OMB control number 0910-0844.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12633 Filed 6-12-18; 8:45 am]
 BILLING CODE 4164-01-P