FDA to make 510(k) changes by September

Meet the new boss, who is definitely not the same as the old boss.

The Center for Devices and Radiological Health and new director Jeffrey Shuren are looking to shake things up at the Food & Drug Administration’s medical device oversight arm, according to a new set of strategic priorities for 2010 and the following years. The changes include an overhaul of the 510(k) and PMA approval processes, slated to go into effect by September, and a 2013 release date for a unique device identifier system.

The new directives, outlined in four parts on the agency’s website, include implementing a “total product life cycle approach,” enhancing communication and transparency, strengthening its workforce and finding new ways to address unmet public needs.

Of most pressing interest to medical device firms is the overhaul of the 510(k) and PMA approval processes, which will move even faster than most industry experts thought. The agency has already started internal and external reviews of the 510(k) clearance process, but the timeline for implementing changes is considerably shorter than previously thought. Some 3,000 medical devices — the majority of the medical device clearance applications submitted to the FDA — are evaluated each year through the 510(k) program.

The FDA is already conducting its own 510(k) review along with a $1.3 million, FDA-commissioned report from the Institute of Medicine, which are both slated for release in June 2011.

But it appears the agency is looking to implement changes recommended by its internal 510(k) Working Group before then. Via a multi-step process that includes a public meeting Feb. 28 and an “all hands meeting” of CDRH staff March 31, the FDA plans to implement some changes by Sept. 30. And the agency will take a closer look at Class III devices that enter the market through the 510(k) program.

CDRH is also looking more closely at the quality of clinical evidence it uses to approve devices via the more rigorous PMA (pre-market approval) process. An assessment of those standards is expected by August 31, with a goal of implementing some of the recommendations starting in November.

Other strategic initiatives include:

  • The creation of a timeline for the release of a “Unique Device Identification” (UDI) system, which is slated to launch Sept. 30, 2013;
  • Increased cooperation with regulatory agencies in other countries;
  • Improved transparency and communication, both within the agency and with the public at large;
  • And changes to the scope of the agency’s brief, to include the identification of unmet public health needs and the fostering of the development of medical devices to meet those needs.

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