Scrip 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

Uneasy feeling for US industry as detail emerges of 510(k) overhaul

This article was originally published in RAJ Devices

Executive Summary

"These two preliminary reports recommend steps to strengthen and improve the 510(k) process and the use of science in decision making" and provide a "blueprint for smarter medical device oversight". That is the understated way in which Jeffrey Shuren, director of the US Food and Drug Administration's Center for Devices and Radiological Health, described what are likely to be the biggest changes to the regulation of low- to medium-risk medical devices for 34 years1.

Advertisement
Advertisement
UsernamePublicRestriction

Register

SC096230

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