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# FDA Makes Technical Changes to HDE, IRB Regs
- URL: https://www.fdaweb.com/fda-makes-technical-changes-to-hde-irb-regs/
- Published: 2017-06-06T12:00:00.000Z
- Updated: 2026-09-14T22:27:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138863

FDA says it is amending regulations to reflect changes enacted into law by the 21st Century Cures Act. A *Federal Register* [notice](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwNjA2Ljc0MjI0MzcxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDYwNi43NDIyNDM3MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDIxMzAxJmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-11816.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says that certain requirements related to humanitarian device exemptions (HDE) and institutional review boards (IRB) for devices have changed. The changes are: 

- allowing 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
- removing the requirement that institutional review boards for devices be “local.”