Requirements for obtaining Food and Drug Administration (FDA) approval are “uncertain” or “unclear”, say 75% of medical device industry officials who participated in an online survey conducted from December 22, 2010 through February 22, 2011.
Executed by researchers from Northwestern University in Chicago, Illinois and paid for by the Institute for Health Technology Studies (InHealth), a nonprofit foundation that receives funding from the medical device industry, the survey includes feedback from about 350 executives. Of these respondents, 72% also characterized information requests from FDA reviewers as going beyond the requirements established in guidance documents. Representatives from two-thirds of small medical device and diagnostic companies queried said they routinely garner approval for new products in Europe before experiencing the same in the U.S.
Regulations that affect the 510(k) process—e.g., procedures for obtaining FDA approval of medical devices--are currently being re-written by officials at FDA's Center for Devices and Radiological Health (CDRH). The procedures are intended to be applicable to devices that are similar to a product already on the market. The FDA has also requested that the independent Institute of Medicine (IOM) share its perspective on some of the most controversial proposals before the agency decides how to proceed. The IOM report is expected to be released this summer.
According to CDRH Director Jeff Shuren, the agency has strived diligently to identify changes that will improve the predictability and consistency of FDA pre-market review programs. After collecting public comments on a series of proposed recommendations, CDRH officials in January announced 25 steps they will take this year to update the process.
Shuren says the results of the study “further validate the actions” CDRH is already taking in this regard, for example, developing guidance, introducing new training programs, and streamlining the de novo process for lower-risk innovative devices. While such efforts “may not grab headlines”, he adds, they represent true strategies being initiated by the agency taking “to promote and protect the public health.”
The Northwestern survey is part of a larger study. Over the next several months, the researchers will expand upon it by compiling case studies and performing an in-depth analysis of U.S. and EU regulatory procedures.