HUMANITARIAN USE DEVICES REGULATED VIA TWO-STEP PREMARKET APPROVAL PROCESS UNDER FINAL RULE; CLINICAL SAFETY DATA MAY BE REQUIRED FOR SOME EXEMPTIONS
This article was originally published in The Gray Sheet
Humanitarian use devices can be distributed through a two-step premarket approval process rather than the investigational device exemption process, FDA says in a final rule implementing HUD provisions of the Safe Medical Devices Act of 1990. The rule, which is slated to appear in the Federal Register the week of June 24 and take effect 120 days after publication, reverses the agency's December 1992 proposal to regulate HUDs via IDE rules.
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