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


Third-party inspections

This article was originally published in The Gray Sheet

Executive Summary

Sen. Edward Kennedy (D-Mass.) will monitor the progress of the U.S./EU mutual recognition agreement (MRA) program before committing to any proposal authorizing third-party inspections of medical device manufacturers, HELP Committee staff suggests. Third-party inspection and review provisions within the Greenwood/Eshoo device reform measure (HR 3580) were chief obstacles to device user fee passage as part of the PDUFA reauthorization package currently awaiting the President's signature (1"The Gray Sheet" May 27, 2002, p. 3). Although industry proponents, including AdvaMed, still hope to fasten user fees to Greenwood/Eshoo, HELP staffers indicate Kennedy remains opposed to third-party reforms without evidence of their benefit. Among issues to be resolved are whether third-party inspections can be conducted while avoiding conflicts of interest. The General Accounting Office has indicated that data are insufficient for analysis of third-party and reuse issues requested by Kennedy earlier this year...

You may also be interested in...

Kennedy To Industry: User Fees Still In Play If Third Party Sits This One Out

Industry supporters of medical device user fees are assuming a formidable challenge by linking the legislative proposal with the "Medical Device Amendments of 2001" (HR 3580), introduced by Reps. Jim Greenwood (R-Penn.) and Anna Eshoo (D-Calif.)

COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers

First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.




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