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

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDA issues final guidances on 513(g) requests for information on device classifications. Panel to meet June 13 on expanded indication for Sapien transcatheter valve. More FDA news.

You may also be interested in...



Edwards Wins Approval For Sapien Just In Time For TCT

Regulatory News In Brief

510(k) modifications guidance

FDA Releases Draft Guidelines On 513(g) Device Classification Requests

FDA released two draft guidances April 29 to help firms better understand the agency's 513(g) device classification request program - and when the costly voluntary filings are unnecessary

Topics

UsernamePublicRestriction

Register

OM004514

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