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

Rx Bill Concedes Devices Distinct From Drugs, Yet Carries Device Provision

This article was originally published in The Gray Sheet

Executive Summary

FDA would be required to submit a report identifying the "deficiencies" in device postmarket surveillance under a bill establishing an independent drug postmarket safety office

You may also be interested in...



Senate Passes User Fee Reauthorization With FDA/Industry Proposals Intact

Legislation reauthorizing the medical device user fee program passed the Senate May 9. Action is now needed in the House to prevent the program from expiring on September 30

Senate Passes User Fee Reauthorization With FDA/Industry Proposals Intact

Legislation reauthorizing the medical device user fee program passed the Senate May 9. Action is now needed in the House to prevent the program from expiring on September 30

Heightened Device Postmarket Oversight Contingent On Drug Bill, FDA Report

Congress could consider specific device postmarket surveillance legislation if a report included in the drug safety bill concludes that intensified oversight is necessary, according to Hill staffers

UsernamePublicRestriction

Register

MT022037

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