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


Scrutinizing 510(k)s: Critical Voices Get Heard In Congress

This article was originally published in The Gray Sheet

Executive Summary

Consumer advocacy groups have recently stepped up efforts to publicly scrutinize FDA's 510(k) premarket notification process for devices and push for a higher burden of proof for getting the products to market

You may also be interested in...

A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path

510(k) clearances are the US market on-ramp for most devices, and proving the device is similar enough to an already-marketed product is the entry toll. But a policy in development at FDA's device center offers an optional approach that avoids predicate comparisons. Center director Jeffrey Shuren says in an interview that he expects the new approach will become the "pathway of choice" for many companies, potentially upending what has been a defining characteristic of the device regulatory landscape for decades.

People In Brief

Sidney Wolfe steps aside as director of Public Citizen’s Health Research Group more than 40 years after co-founding the consumer advocacy group. White House recognizes device entrepreneur. More personnel news.

Lurie Joins FDA: Critic Of Agency, Industry Will Help Make Regulatory Policy

One of the most outspoken critics of the device industry and FDA's device center has been named to a top-level position within the agency

Related Content




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