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

Industry Looking For More “Abbreviated” Review Times In 510(k) Program

This article was originally published in The Gray Sheet

Executive Summary

Lackluster industry participation in the abbreviated 510(k) and third-party review programs could hinder efforts to adopt provisions giving device manufacturers the option of being inspected by a third party

You may also be interested in...



510(k) Review Times, CDRH Personnel Moves Unveiled At RAPS

Improved coordination between CDRH premarket guidance and standards development will be facilitated by Office of Device Evaluation Deputy Director Phil Phillips, who is assuming a parallel role as deputy director of the Office of Science & Technology

510(k) Review Times, CDRH Personnel Moves Unveiled At RAPS

Improved coordination between CDRH premarket guidance and standards development will be facilitated by Office of Device Evaluation Deputy Director Phil Phillips, who is assuming a parallel role as deputy director of the Office of Science & Technology

CDRH’s Marlowe To Coordinate FDA Science Standards; Kessler Will Head OST

Donald Marlowe, director of the Office of Science & Technology at the device center since April 1995, stepped into the newly created position of standards administrator for FDA's Office of Science & Health Coordination Oct. 7

Related Content

UsernamePublicRestriction

Register

LL026487

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