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

FDA Proposes Status Reports, Web Postings For Postmarket Studies

This article was originally published in The Gray Sheet

Executive Summary

Device firms should submit interim status reports on mandated post-approval studies to FDA every six months for a study's first two years and annually thereafter, a newly released draft guidance states

You may also be interested in...



Compliance With Post-Approval Commitments Goes Public On CDRH Web Site

A Web site that will publicly display the status of FDA-required post-approval medical device studies will be operational within weeks, according to Steven Chasin, deputy director of the postmarket surveillance division at CDRH's Office of Surveillance & Biometrics

Compliance With Post-Approval Commitments Goes Public On CDRH Web Site

A Web site that will publicly display the status of FDA-required post-approval medical device studies will be operational within weeks, according to Steven Chasin, deputy director of the postmarket surveillance division at CDRH's Office of Surveillance & Biometrics

Medtronic Cited For Late Postmarket Report; First “522” Action Under FDAMA

An FDA 1warning letter sent to Medtronic Sept. 27 is the agency's first enforcement action under its 1997 powers to compel device makers to collect specified postmarket surveillance data

Related Content

UsernamePublicRestriction

Register

LL010986

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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