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

Congress Enters Final Stages On FDA Reform Bill

This article was originally published in The Gray Sheet

Executive Summary

Legislative leaders say they remain on track to send FDA user fee reauthorization and reform legislation for the president’s signature by the end of June following House passage of bill.

You may also be interested in...



New Massachusetts Senator Ed Markey Targeted ‘Defective Devices’ As House Member

Democrat Ed Markey was elected to the Senate in a Massachusetts special election June 25. In the House, he was a strong supporter of pediatric device development but also a vocal critic of industry and FDA’s device safety oversight. In particular, he has pushed for reforms to the 510(k) system that could limit companies’ use of predicate devices in 510(k) submissions.

New Massachusetts Senator Ed Markey Targeted ‘Defective Devices’ As House Member

Democrat Ed Markey was elected to the Senate in a Massachusetts special election June 25. In the House, he was a strong supporter of pediatric device development, but also a vocal critic of industry and FDA’s device safety oversight. In particular, he has pushed for reforms to the 510(k) system that could limit companies’ use of predicate devices in 510(k) submissions.

FDA Issues Work Plan For Independent Assessment Of Pre-market Review Process

The assessment, called for by industry during the device user fee reauthorization, will be conducted by an independent consulting firm. The goal is to identify efficiencies in the device review process.

Related Content

Topics

UsernamePublicRestriction

Register

LL1133148

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