Source: https://www.federalregister.gov/documents/2018/06/13/2018-12633/humanitarian-device-exemption-program-draft-guidance-for-industry-and-food-and-drug-administration
Timestamp: 2018-08-20 15:30:19
Document Index: 672035665

Matched Legal Cases: ['art 10', 'arts 50', 'art 54', 'art 803', 'art 812', 'art 814', 'art 814', 'art 820']

Federal Register :: Humanitarian Device Exemption Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Humanitarian Device Exemption Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Docket No. FDA-2014-D-0223
FDA-2014-D-0223
https://www.federalregister.gov/d/2018-12633 https://www.federalregister.gov/d/2018-12633
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Humanitarian Device Exemption (HDE) Program.” This draft guidance concerns the HDE program as a whole and, among other topics, it explains the criteria FDA considers to determine if “probable benefit” has been demonstrated as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 The draft guidance also incorporates recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that affect the HDE program and answers other common questions that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 This draft guidance is not final nor is it in effect at this time.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 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. Start Printed Page 27615
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.
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.
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.
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.
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.
Persons interested in obtaining a copy of the draft guidance may do so by Start Printed Page 27616downloading 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 CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17040 to identify the guidance you are requesting.
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.
[FR Doc. 2018-12633 Filed 6-12-18; 8:45 am]