The 510(k) Working Group was established in September 2009, tasked with evaluating the program and exploring actions CDRH could take to enhance decision-making. Anticipation of the changes has caused no end of worry for device makers. Uncertainty in the regulatory arena has been directly linked to slowing investments in medical device innovation, according to a recent survey, “Medical Innovation in a Time of Upheaval,” conducted by PRTM and MassMEDIC.

The reactions from trade groups came swiftly. AdvaMed released an advisory to its members, noting that the recommendations contained both positives and negatives. The association praised improvements such as the creation of Class IIb devices (see the sidebar “Highlights of Proposed Changes to 510(k)”). Stephen Ubl, AdvaMed’s president and CEO, also said that “The proposals to increase the consistency and predictability of the process by greater reviewer training and oversight are very promising and, if successful, will address one of the most troublesome issues companies currently face in bringing new products to market.”

However, AdvaMed also called attention to more troubling aspects of the report, particularly the sheer volume of the recommendations and their inherent costs. “There are in excess of 70 proposed changes that, taken together, could result in a significant disruption to a program that has served patients well for more than 30 years,” Ubl said. “These range from potential changes in the fundamental basis for product clearance to publicly disclosing design schematics in a database where foreign competitors would have access to them.”

Mark Leahy, president and CEO of the Medical Device Manufacturers Association (MDMA), agrees that the size and scope of the report deserves careful consideration. “The collective impact of so many changes would be significant,” he says.

Nonetheless, Leahy takes a collaborative approach to the proposals. “MDMA looks forward to working with FDA officials and other organizations and making sure that any changes to this highly successful process are driven by data and science and do not unintentionally create barriers to patient care or innovation.”

Leahy also says that it is industry’s responsibility to get involved with the process. “We are encouraging all of our members and stakeholders to carefully review these recommendations and provide their comments to FDA, as they could have a lasting effect on the industry,” he says.