First Steps towards 510k reform

In response to growing concerns about the 510(k) process raised by numerous parties include the US Congress the FDA has initiated a review of the 510(k) program. As a first step the FDA has conducted an internal review and they have recently released these internal reports for public comment. The key findings and recommendations presented in the reports are outlined below:

• The de novo process was found to be significantly overburdensome and it is recommended that steps be taken to streamline the process including limiting the regulatory oversight based on appropriate risk assessment.
• To date it has been very unclear which 510(k) submissions require clinical evidence. The FDA proposes to establish a new Class IIb classification for products that would require clinical evidence in a 510(k) submission. 
• Introduction of a “Notice to Industry” system that would provide more timely guidance to industry on changing regulatory expectation, than the current formal guidance process.
• New and explicit requirements for manufacturers to submit a summary of all known scientific information related to the safety or performance of the device in a 510(k).  This is aimed directly at preventing the selective presentation of only favourable evidence to FDA.
• The FDA proposes to include much more detailed device information in 510(k) database including photographs, up-to-date labelling, design schematics as well as the FDA review decisions.
• FDA seems to be aware of a lack of expertise and consistency with its reviewers and are planning on taking steps to increase reviewer knowledge and consistency of review practices across the CDRH.

Note that all these are simply recommendations at this stage and open to public comment. Watch this space for announcements on comments!

It is still VERY early days in this process. The FDA has commissioned the Institute of Medicines to undertake an independent review of the 510(k) and their report is not expected until July 2011. Expect further consultations and eventually updates to the regulations and potentially the Act, all of which will take time.

In some ways these reforms represent some small steps towards the GHTF  regulatory model – this is essentially introducing a four step classification and is placing a greater emphasis on clinical evaluation – which, following the recent MDD reviews is now very explicitly part of the European requirements (and also in Australia and other jurisdictions).  There’s still a long way to go on the road to global harmonisation but a journey of a thousand miles starts with a single step…

The full reports are available here: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm

Josh Griffin
Josh@brandwoodbiomedical.com.au