Humanitarian Device Exemption Program; Guidance for Industry and Food and Drug Administration Staff; Availability, 46956-46958 [2019-19290]

Download as PDF 46956 Federal Register / Vol. 84, No. 173 / Friday, September 6, 2019 / Notices 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/201523389.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)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4332, Silver Spring, MD 20993–0002, 301–796–2250. SUPPLEMENTARY INFORMATION: The guidance represents the current thinking of FDA on ‘‘Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older.’’ 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. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. 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 312 have been approved under OMB control number 0910–0014, and the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: September 3, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that RINVOQ (upadacitnib) approved August 16, 2019, meets the redemption criteria. FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4061, Fax: 301–796–9858, email: althea.cuff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that RINVOQ (upadacitnib) approved August 16, 2019, meets the redemption criteria. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDisease PriorityVoucherProgram/default.htm. For further information about RINVOQ (upadacitnib) approved August 16, 2019, go to the ‘‘Drugs@FDA’’ website at https://www.accessdata.fda.gov/scripts/ cder/daf/. [FR Doc. 2019–19291 Filed 9–5–19; 8:45 am] Dated: September 3, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. BILLING CODE 4164–01–P [FR Doc. 2019–19298 Filed 9–5–19; 8:45 am] BILLING CODE 4164–01–P jspears on DSK3GMQ082PROD with NOTICES I. Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older.’’ The guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of POS in pediatric patients. Specifically, this guidance addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the efficacy of drugs approved for the treatment of POS in adults to pediatric patients 2 years of age and older. All the public comments received on the draft guidance have been considered and the guidance has been revised as appropriate, along with editorial changes. This guidance finalizes the draft guidance issued on February 16, 2018 (83 FR 7057). This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). VerDate Sep<11>2014 16:53 Sep 05, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2018–N–1262] [Docket No. FDA–2014–D–0223] Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: Notice. The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the SUMMARY: PO 00000 Frm 00025 Fmt 4703 Humanitarian Device Exemption Program; Guidance for Industry and Food and Drug Administration Staff; Availability Sfmt 4703 Food and Drug Administration, HHS. ACTION: Notice of availability. 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 SUMMARY: E:\FR\FM\06SEN1.SGM 06SEN1 Federal Register / Vol. 84, No. 173 / Friday, September 6, 2019 / Notices 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. 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: DATES: 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’’). jspears on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 16:53 Sep 05, 2019 Jkt 247001 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/201523389.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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 46957 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 E:\FR\FM\06SEN1.SGM 06SEN1 46958 Federal Register / Vol. 84, No. 173 / Friday, September 6, 2019 / Notices 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 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/ GuidanceComplianceRegulatory Information/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 Act section Topic 807, 812, 814 ............................................ 814 ............................................................ 814, subparts A through E ....................... 814, subpart H .......................................... 812 ............................................................ ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. 803 ............................................................ Acceptance of Data from Clinical Investigations for Medical Devices ........................ Pediatric Uses of Devices ............................................................................................ Premarket Approval ..................................................................................................... Humanitarian Device Exemption .................................................................................. Investigational Device Exemption ................................................................................ De Novo classification process .................................................................................... 0910–0741 0910–0748 0910–0231 0910–0332 0910–0078 0910–0844 Medical Devices; Medical Device Reporting; Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements. Protection of Human Subjects: Informed Consent; Institutional Review Boards ........ Institutional Review Boards .......................................................................................... Administrative Practices and Procedures .................................................................... Financial Disclosure by Clinical Investigators .............................................................. 0910–0437 820 ............................................................ 520(m) of the FD&C Act ........................... 50, 56 ........................................................ 56 .............................................................. 10 .............................................................. 54 .............................................................. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: jspears on DSK3GMQ082PROD with NOTICES applicable statutes and regulations. This guidance is not subject to Executive Order 12866. In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has SUMMARY: VerDate Sep<11>2014 16:53 Sep 05, 2019 Jkt 247001 scheduled a public meeting. Information about ACHDNC and the agenda for this meeting can be found on the ACHDNC website at: https://www.hrsa.gov/ advisory-committees/heritabledisorders/. DATES: September 24, 2019, 10:00 a.m.– 1:00 p.m. Eastern Time (ET). ADDRESSES: This meeting will be held via webinar. While this meeting is open to the public, advance registration is required. Please visit the ACHDNC website for information on registration: https://www.hrsa.gov/advisorycommittees/heritable-disorders/ index.html. The deadline for online registration is 12:00 p.m. ET on September 23, 2019. Instructions on how to access the meeting via webcast will be provided upon registration. FOR FURTHER INFORMATION CONTACT: Alaina Harris, Maternal and Child Health Bureau (MCHB), HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301–443–0721; or ACHDNC@ hrsa.gov. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 OMB control No. 0910–0073 0910–0661 0910–0755 0910–0130 0910–0191 0910–0396 ACHDNC provides advice and recommendations to the Secretary of HHS (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. ACHDNC’s recommendations regarding inclusion of additional conditions for screening, following adoption by the Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA through the Recommended Uniform Screening Panel (RUSP) pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg– 13). Under this provision, nongrandfathered group health plans and health insurance issuers offering group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, coinsurance, or deductible) for preventive SUPPLEMENTARY INFORMATION: E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:

------------------------------------------------------------------------
 21 CFR part, guidance, or FD&C                            OMB  control
          Act section                     Topic                 No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


    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

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