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# Amendments Made to HDE and IRB Rules
- URL: https://www.fdaweb.com/amendments-made-to-hde-and-irb-rules/
- Published: 2017-06-07T12:00:00.000Z
- Updated: 2026-09-14T22:27:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138881

*Federal Register* Final Rule technical amendment: 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 for devices have changed. The changes allow for HDE approval for devices that, among other things, treat or diagnose a disease or condition that affects not more than 8,000 individuals (previous threshold had been fewer than 4,000 individuals); and remove the requirement that institutional review boards for devices be “local.” To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-06-07/pdf/2017-11816.pdf?ref=fdaweb.com).