Jan 19, 2011

The US Food and Drug Administration (FDA) has rolled out some — but not all — long-awaited changes to its 510(k) premarket notification process for clearing moderate-risk medical devices.

The FDA’s new proposal addresses 25 out of its original 55 recommendations issued in August 2010, delaying action on the more contested components of its reform plan — such as the formation of the new Class IIb device category, regulatory authority to rescind 510(k) clearances and increased post-market surveillance requirements — until the conclusion of an independent evaluation of those proposals by the Institute of Medicine, expected mid 2011.

Major reform elements the FDA’s Center for Devices and Radiological Health (CDRH) division does plan on implementing this year include:

  • Streamlining the Class III de novo classification process,
  • Clarifying the conditions under which 510(k) applicants must submit clinical data in order to make their review processes more efficient,
  • Forming a Center Science Council made up of senior FDA experts to develop business processes and standard operating procedures.

Other action items included in the FDA’s announcement include guidance to improve clinical trial quality; clarify processes for appealing 510(k) rescission; and to consistently develop and assign unique product codes. Plans to improve collection and analysis of postmarket data; communications regarding changes in regulatory requirements based on new scientific findings; and improve the IDE process will also be implemented this year.

The action items categorized as draft guidances and proposed regulations will feature individual comment periods prior to finalization. Further details regarding comment periods as well as implementation timelines is available on the FDA website.

Medical device industry participants and observers have engaged in months-long lobbying efforts to ensure that the ultimate iteration of the regulator’s 510(k) reform imposes minimal additional challenges to obtaining clearance to sell their product(s) in the US market. Although the FDA’s latest announcement should answer many questions about how the agency’s reforms will be implemented, the issues that will have the most significant potential impact on medical device manufacturers have yet to be fully addressed. As such, firms will have to wait until summer to find out how the FDA’s most important 510(k) reform proposals will affect them.


  • Stewart Eisenhart