The FDA’s Center for Devices & Radiological Health has had an earful of complaints regarding its device review process, but the federal watchdog agency is making strides in changing its culture and regulating smarter.
In August 2010, CDRH released the results of public surveys detailing shortcomings at the agency, finding that a lack of predictability in the pre-market approval program was the number one problem.
In January the agency announced its response, a “Plan of Action” laying out 25 specific steps toward improving predictability.
Since then, the CDRH has established a science council, developed an online labeling repository and launched an FDA reviewer certification program, among other things.
The agency’s plans fit into three categories:
- Fostering transparency, interaction and collaboration
- Keeping recommendations and decisions predictable
- Ensuring efficiency in use of resources
Toward those ends, CDRH has made moves to improve collaboration by tapping industry to modify the interactive review and improve pre-submission meetings. The agency also plans to make greater use of external experts and implement a balanced approach to weighing benefits and risks of new devices.
Still left on the docket for this year is the development of a unique device identification system, clarification on third-party review and two regulation proposals for medical device labeling and 510(k) ownership transferring. And there are still five more draft guidances on the way.
In its audit of the last two years CDRH outlined three broad needs to ensure further progress:
- Continued momentum in improving the device review process
- Collaboration with industry to ensure incoming applications are high quality
- Additional resources to keep things moving
"We believe that if these three things are accomplished we will provide the kind of value that patients deserve and have come to expect from the FDA – timely access to safe and effective devices that address their health care needs," according to an agency report. "And the medical industry will have the kind of predictable, consistent, transparent, and efficient pathways to market that spur continued innovation."