Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

Executive Summary

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.
UsernamePublicRestriction

Register

MT006224

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel