FDA changes that are now in effect.

June 27, 2017

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.


Changes include:

  • This final rule amends § 814.3(n) by removing the words “fewer than 4,000” and adding in their place the words “not more than 8,000”.
  • This final rule also amends 21 CFR 814.124(a), “IRB approval”, to remove the term “local” and related language in order to accurately reflect the requirements recently enacted into law.  As part of the medical device regulatory process improvements, Institutional Review Boards (IRB) responsible for reviewing plans for clinical testing of a medical device no longer need to be local.  Medical device sponsors conducting certain types of clinical trials may now rely on central IRB rather than local IRB for reviews required by the US Food and Drug Administration.

Effective Date: This rule became effective on June 7, 2017.


View US FDA Final Ruling