# Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2017-06-07 · Effective 2017-06-07 · 82 FR 26348
## Document
- **Document number:** 2017-11816
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 26348
- **CFR reference:** 21 CFR 814
- **Publication date:** 2017-06-07
- **Effective date:** 2017-06-07
- **HHS docket:** Docket No. FDA-2017-N-0011
## Abstract

The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/06/07/2017-11816/humanitarian-use-devices-21st-century-cures-act-technical-amendment)
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