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

FDA To Tackle Tough Pre-, Post-Market Issues At 510(k) Workshop

This article was originally published in The Gray Sheet

Executive Summary

FDA's upcoming public meeting on strengthening the 510(k) review process will explore issues in four key areas: predicate devices; new technologies and scientific evidence; practices for managing the high volume of 510(k) submissions; and post-market surveillance
Advertisement

Related Content

Shuren's CDRH Sets Ambitious 2010 Agenda: 510(k), PMA Changes Planned
Shuren's CDRH Sets Ambitious 2010 Agenda: 510(k), PMA Changes Planned

Topics

Advertisement
UsernamePublicRestriction

Register

MT028437

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