Though 510(k) Program Faced Heavy Criticism, Numbers Showed It to Fared Better than PMAs

As 2011 draws to a close, FDA finds itself dealing with criticism on multiple fronts. Many device makers are unhappy with what they see as an inconsistent, unpredictable agency regulating industry at an onerously slow pace. Consumer advocates, on the other hand, are alarmed by what they see as an agency with unduly weak regulatory authority allowing potentially dangerous devices to enter the market. In the middle is FDA.

In July, the Institute of Medicine (IOM) released the now infamous report calling for FDA to scrap the 510(k) process. The group argued that the practice of clearing medical devices based on their similarity to other, previously approved medical devices was too risky and should be replaced with a stricter, more rigorous approach. The criticism caused both industry and FDA to defend the 510(k) process.

While the numbers detailed by CDRH’s FY 2010 MDUFA Performance Report to Congress do not necessarily indicate the effectiveness of the 510(k) process, they do seem to show that the agency is much better at handling 510(k) submissions than premarket approval (PMA) submissions. The agency met both its tier 1 and tier 2 goals for 510(k)s in FY 2009 and has the potential to meet them for FY 2010. It met only its tier 1 goal for PMAs in FY 2009 and may still fail to meet its tier 2 goal for PMAs in FY 2010.

It should be noted that there is a difference between how the agency measures the time it takes to process a submission and how industry measures it. Because the agency “stops the clock” when, say, it requests additional information from manufacturers, the data that it uses to gauge whether it has met its performance goals do not necessarily reflect the actual time used to process submissions.

The report also references the agency’s promise to provide quarterly performance updates, which it has continued to make good on in FY 2011. Four updates were disseminated in 2009 and 2010, and three have been published so far this year. The most recent report, published in late July, included more up-to-date submission data than did the annual report, including nearly complete data on PMA submissions for FY 2010. In addition, the agency touted its promise to publish more guidance documents in FY 2010, mentioning that it developed 16 guidances meant to help industry with issues related to MDUFA II. This year, the agency has published several more guidance documents.

With negotiations currently underway for the reauthorization of MDUFA II, the regulatory framework currently in place is still liable to change, even if the 510(k) remains the dominant means of getting a device to market. Between that and the shifting political realities of Washington, DC, the agency’s future is still very much in flux.