US FDA plans September meeting to discuss IOM proposal to scrap 510(k)
This article was originally published in RAJ Devices
The US Food and Drug Administration is to hold a public meeting on 16 September to discuss the controversial Institute of Medicine report that calls for the agency to replace the pre-market notification process it uses to clear most medium- and low-risk medical devices with an entirely new framework1.
The FDA's announcement of the meeting comes days after the New England Journal of Medicine published an article on 10 August that criticised the agency for its dismissive response to the IOM's recommendation to abandon the pre-market notification, or 510(k), process2,3.
In the article, NEJM executive editor Gregory D Curfman and the Archives of Internal Medicine's editor, Rita F Redberg, noted that "unfortunately, the FDA leadership has already suggested that it does not intend to implement this key recommendation of the report, although it may be open to other changes".
The authors believe that the IOM report is insightful, judicious, sensible and long overdue. In the article, they express support for replacing the 510(k) process with an evaluation of safety and effectiveness. They note that the 510(k) procedure was established 35 years ago, "and although it may have been a reasonable approach then, it surely is not today".
The FDA's public meeting to discuss the IOM recommendations will be held in Silver Spring, Maryland. The agency is looking for feedback on all of the eight recommendations in the report that call upon the agency to:
- obtain adequate information to inform the design of a new medical device regulatory framework for Class II devices so that the current 510(k) process can be replaced with an integrated pre-market and post-market regulatory framework;
- develop and implement a comprehensive strategy to collect, analyse and act on medical device post-market performance information;
- review its post-market regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed;
- investigate the viability of a modified de novo process as a mechanism for evaluating the safety and effectiveness of Class II devices;
- develop and implement a programme of continuous quality improvement to track regulatory decisions on medical devices, identify potential process improvements in the medical device regulatory framework and address emerging issues that affect decision-making;
- commission an assessment to determine the effect of the agency's regulatory process for Class II devices on facilitating or inhibiting innovation in the medical device industry;
- develop procedures that ensure the safety and effectiveness of software used in devices, software used as devices and software used as a tool in producing devices; and
- promptly call for pre-market approval applications for, or reclassify, Class III devices that remain eligible for 510(k) clearance.
Regardless of attendance at the public meeting, the FDA says it will accept comments from interested persons on these recommendations until 30 September.
References
1. Federal Register, 12 August 2011, 76(156), 50230-50231, www.gpo.gov/fdsys/pkg/FR-2011-08-12/pdf/2011-20575.pdf
2. Curfman GD and Redberg FR, Medical Devices – Balancing Regulation and Innovation, NEJM, 10 August 2011, http://healthpolicyandreform.nejm.org/?p=15108#more-15108
3. US FDA invites feedback on IOM advice to scrap 510(k) process, Regulatory Affairs Medtech, 1 August 2011