Despite some prior indications that the 510(k) process would remain as-is for now, it seems 510(k) reform is now taking a prominent spot on the FDA's agenda for 2010, with one report saying "revisions" to the pathway should be in place by September 30th.
It's unclear exactly what will change and how extensive these changes will be, but we have some insight into the topics in which the agency has take a keen interest. On the tail of Jeff Shuren's permanent appointment as director of the CDRH came the announcement that the FDA would hold a public meeting on February 18th to gain feedback on the 510(k) process. The event, which will be webcast live, will consider issues related to predicate devices, new technologies and scientific evidence, high submission volume and post-market surveillance.
In a statement from the FDA, Shuren said, "We are looking forward to hearing from the public on issues related to [the 510(k)] to help us improve it." The meeting will be focused around the four issues above, with an open comment section for each topic, and will conclude with a roundtable discussion between meeting participants and FDA staff. In their federal register notice, the FDA included a list of questions to help solicit comments.
While the FDA is evaluating the 510(k) pathway internally, the IOM is also conducting its own review. Commissioned by the agency in September 2009, the IOM study is expected to address, in particular, post-market surveillance, increasing transparency and establishing internal conflict resolution procedures within the 510(k) process. That report is due in 2011.
