Regulatory Focus™ > News Articles > Proposed Medical Device Postmarketing Surveillance System Moves Forward

Proposed Medical Device Postmarketing Surveillance System Moves Forward

Posted 04 September 2012 | By Alexander Gaffney, RAC 

Regulators with the US Food and Drug Administration (FDA) want to bolster the surveillance of already-approved medical devices, and are calling for public feedback on what the ideal system for conducting such surveillance might look like.

In a 30 August Federal Register posting, FDA noted that, "Several high-profile device performance concerns have led some to question whether the Center for Devices and Radiological Health's (CDRH) current postmarket surveillance system is optimally structured to meet the challenges of rapidly evolving medical devices and the changing nature of health care delivery and information technology."

Regulators also pointed to a July 2011 recommendation from the US Institute of Medicine (IOM) which called for FDA to establish a comprehensive strategy and system to collect and analyze data on medical devices.

Of particular concern to the IOM panel which formulated the recommendation are medical devices cleared through FDA's 510(k) process, which requires manufacturers to show their device is substantially equivalent to an already-approved predicate device. The devices cleared through this pathway are subject to less rigorous approval standards than are its non-predicate counterparts, and have suffered from several highly publicized failures, including metal-on-metal hip implants and surgical mesh products.

FDA to Release Plan in Advance of Meeting

FDA said the meeting, to be held 10 September 2012, is intended to collect public input on the formulation of this medical device surveillance strategy, as well as to, "Discuss the current and future state of medical device postmarket surveillance." Key questions are to include whether the system is needed at all, the general guiding principles for the program, the attributes of the system and ways in which FDA could leverage its existing resources.

FDA also said it plans to release a preliminary report before the meeting detailing CDRH's preferred plan, though no preview of this report was provided in the Federal Register notice.

Participants may sign up for the meeting using a form on FDA's website.

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