Upcoming Changes at FDA
FDA is undertaking an extensive review of its 510(k) approval process, one of six priority areas for the Center for Devices and Radiological Health (CDRH). The Institute of Medicine has been commissioned to examine the strengths and weaknesses of the FDA premarket notification program and issue recommendations for improving the system. Their final report will be issued in March 2011.
At the same time, CDRH has convened an internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process. A public meeting entitled "Strengthening the Center for Devices and Radiological Health's 510(k) Review Process" has been scheduled by FDA for February 18, 2010. Office of Device Evaluation (ODE) Director Dr. Donna Bea Tillman intends to better understand challenges related to the 510(k) process, particularly when determining whether a new device represents a new indication for use compared to predicate devices. She will be alerted to all 510(k) submissions with novel indications not seem previously in that device type, as part of the program review process. Later this year ODE also plans to update the guidance on when to submit a new 510(k) for changes to an existing device.
The FDA actions come on the heels of a January 2009 GAO report critical of the FDA premarket review process. Among its findings, the GAO noted an increasing number of class III devices receiving 510(k) clearance, as opposed to the more stringent PMA process. It recommended the FDA "expeditiously take steps to issue regulations for each class III device currently allowed to enter the market through the 510(k) process."
In response to mounting pressure from Congress and the public concerning the 510(k) approval of the ReGen Menaflex device, FDA recently conducted an internal review of its processes in this case. A preliminary report issued on September 2009 found multiple departures from FDA processes, procedures and practices. These findings indicate that a focused scientific reevaluation of the Menaflex decision is warranted. Among its other recommendations the report calls for an independent review of the 510(k) program.
Clearly this is a time of some uncertainty and a transition period at FDA. What had previously been thought of as standard procedure is no longer the case. Medical device companies will be well advised to carefully chart their regulatory route, closely interacting with the Agency in order to minimize uncertainty, and reduce the potential for expensive duplication of development efforts, especially pertaining to the conduct of clinical trials.