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

US FDA consults on fulfilling obligations for device post-market surveillance studies

This article was originally published in Clinica

Executive Summary

The US FDA is seeking feedback on a draft guideline that explains how medical device manufacturers can fulfil requirements relating to post-market surveillance studies ordered under Section 522 of the Federal Food, Drug and Cosmetic Act.