Medtech Insight is part of the Business Intelligence Division 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

US FDA, AAMI Consider Device Benefits And Risks In Post-market Phase

This article was originally published in SRA

Executive Summary

Efforts by the US Food and Drug Administration and industry to clarify benefit-risk considerations for medical devices have moved into the post-market space, with the FDA draft guidance and a draft report from a working group led by the Association for the Advancement of Medical Instrumentation (AAMI), both issued on June 151-3.

Advertisement
Advertisement
UsernamePublicRestriction

Register

MT040819

Ask The Analyst

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

All set! This Question has been sent to 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