Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

GAO Drafts 510(k) Report; Talk Grows Of Pre-Market Reform Legislation In ’09

This article was originally published in The Gray Sheet

Executive Summary

After some delay, the Government Accountability Office has drafted a report on FDA's 510(k) submissions program, which some expect will recommend reforms to the Class II, medium-risk category of devices

You may also be interested in...



GAO Report On 510(k) Program Calls For Regulations On 20 Device Types

A long-awaited government report on the premarket review process for devices says FDA needs to decide "expeditiously" how to review 20 types of devices: through the stringent PMA approval process or through the less rigorous and faster 510(k) clearance process

GAO Report On 510(k) Program Calls For Regulations On 20 Device Types

A long-awaited government report on the premarket review process for devices says FDA needs to decide "expeditiously" how to review 20 types of devices: through the stringent PMA approval process or through the less rigorous and faster 510(k) clearance process

ODE Chief Tillman Defends 510(k) Program At Minnesota Industry Meeting

FDA's head of device evaluation is defending the agency's handling of 510(k) pre-market notification submissions in the face of criticism from two groups: those who charge the agency has allowed devices on the market without sufficient scientific evidence, and industry representatives who claim that FDA often demands too much from 510(k) applicants

Related Content

Latest News
See All
UsernamePublicRestriction

Register

MT026800

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