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.)
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.