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21 CFR Part 814 Subpart H - Humanitarian Use Devices (HUDs) and Humanitarian Device Exemption (HDE) Pathway for Rare Disease and Pediatric Subpopulation Medical Devices

21 CFR Part 814 Subpart H implements section 515A and section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and creates the Humanitarian…

What 21 CFR Part 814 Subpart H - Humanitarian Use Devices (HUDs) and Humanitarian Device Exemption (HDE) Pathway for Rare Disease and Pediatric Subpopulation Medical Devices requires

21 CFR Part 814 Subpart H implements section 515A and section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and creates the Humanitarian Device Exemption (HDE) marketing pathway for devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in not more than 8,000 individuals in the United States per year. Section 814.100(a) sets the scope of the subpart as implementing FD&C Act sections 515A and 520(m). Section 814.100(b) defines the purpose of section 520(m) - to encourage the discovery and use of devices intended to benefit patients in the treatment or diagnosis of rare diseases or conditions, subject to the 8,000-individual-per-year threshold; the subpart provides procedures for (1) HUD designation of a medical device and (2) marketing approval for the HUD notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required under sections 514 and 515 of the FD&C Act. Section 814.100(c) implements section 515A pediatric-subpopulation information requirements. Section 814.102 governs HUD designation - the applicant submits a request to FDA's Office of Orphan Products Development (OOPD) before submitting an HDE, including identification of the rare disease or condition with specificity, a demonstration that any disease subset is medically plausible, a description of the rare disease and proposed indications for use, and the reasons why such therapy is needed. Section 814.104 governs original HDE applications - the applicant or authorized representative signs the HDE; if the applicant does not reside or have a place of business in the United States, the HDE is countersigned by an authorized U.S. representative; the HDE includes a copy of the OOPD HUD determination and the device-specific application content. Section 814.106 permits HDE amendments and resubmissions for the same reasons and in the same manner as PMAs. Section 814.108 governs supplemental applications after FDA approval. Section 814.110 requires a new HUD designation for a new indication for use. Section 814.112 governs filing - FDA decides within 30 days whether the application is sufficiently complete to permit substantive review and may refuse to file an incomplete application. Section 814.116 governs FDA substantive review. Section 814.118 governs denial or withdrawal of HDE approval for failure to meet section 520(m) requirements, Part 814 requirements, IRB approval conditions, or postapproval requirements. Section 814.120 permits temporary suspension. Section 814.122 sets confidentiality requirements for the HDE file.

Pillar: Medical & Healthcare · Authority: United States Food and Drug Administration, Center for Devices and Radiological Health, implementing sections 515A and 520(m) of the Federal Food, Drug, and Cosmetic Act under 21 USC 360e-2 and 21 USC 360j(m); codified in the Code of Federal Regulations Title 21 Part 814 Subpart H and maintained on a current basis by the Office of the Federal Register · Version: 1.0.0 · Last updated:

Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-814

SHA-256 integrity: 385adc1eece03571617c769c8d6dca87ff0651323990bc1be82a51087c10e173

Primary Citations — 12 traced to source

  • 21 CFR 814.100 - Purpose and scope - implements sections 515A and 520(m) of the Federal Food, Drug, and Cosmetic Act; the purpose of section 520(m) is to encourage the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in not more than 8,000 individuals in the United States per year; provides procedures for HUD designation and HDE marketing approval notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required under sections 514 and 515 of the act
  • 21 CFR 814.102 - Designation of HUD status - the applicant submits a request for HUD designation to FDA's Office of Orphan Products Development (OOPD) prior to submitting an HDE; the request includes statement of HUD request with specificity, applicant identification, description of the rare disease and proposed indications with medical-plausibility demonstration for any subset, and description of the device

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