Guest Commentary

Neil F. O’Flaherty, Olsson Frank Weeda Terman Bode Matz PC

On January 19, 2011, the Food and Drug Administration (FDA) published its much-anticipated initial plan to revise and improve its pre-market notification (510(k)) review program.  The plan outlines 25 actions or tasks that the Center for Devices and Radiological Health (CDRH) intends to implement or undertake this year as part of its program changes.  Some of the more important action items are the anticipated guidance documents intended to clarify various aspects of the 510(k) review program, including how to appeal CDRH 510(k) decisions, when clinical data are necessary to support a 510(k) submission, when device modifications require a new 510(k) submission, when one can file a special 510(k) submission, and other topics.  Click here for the complete plan for 2011.

Obviously, FDA’s plans to improve and streamline the 510(k) review process are welcome, and many of the action items have the potential to accomplish these goals.  However, as with many or most government initiatives, the success or failure of the action items will largely rest in how they are implemented by the agency.  Many of them have the potential to assist industry, but they also could create additional burdens for industry if their implementation is not carefully thought through and managed properly.

In my WLF Legal Backgrounder, FDA’s 510(k) Working Group Report:  How Will It Affect Medical Device Innovation? (Dec. 19, 2010), I discussed and analyzed some of the more controversial 510(k) Working Group recommendations for revising the 510(k) review program, which recommendations were published in early August 2010.  I explained that many of these recommendations also had the potential to benefit industry but also had the possibility to create additional burden or obstacles for industry in obtaining 510(k) clearance for their new or modified technologies.  Action on many of the recommendations discussed in the Legal Backgrounder have been deferred by FDA.  It seems that FDA may be content for now to await the findings and recommendations of the Institute of Medicine (IOM) on the 510(k) review program before the agency proposes or articulates further initiatives on these more controversial recommendations.  IOM’s recommendations are due out later this year.

Deferred topics include increased post-market surveillance authority, creation of a Class IIb classification for medical devices (in addition to the current Class I, II and III), combination of the terms “intended use” and “indications for use” into one regulatory definition/concept, FDA authority to rescind 510(k) clearances, keeping a reserve device for future CDRH review, when a device is no longer available to serve as a predicate, and the possibility of seeking a FDC Act amendment that would allow FDA to consider an off-label use when determining a device’s intended use for purposes of substantial equivalence and clearance.

As I mentioned in my prior article, FDA must take care to achieve its goal of a better 510(k) review program in a way that does not create undue burden for an already highly regulated medical device industry.  As always, it will be interesting to see how the changes to the FDA 510(k) review program unfold.