Critics Slam FDA 510(k) Review Changes as Politically-Driven

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Grandstanding or Good Government? Besides the nice alliterative ring to it, that about sums up the heated debated surrounding the FDA’s recent proposed modifications to its 510(k) medical device review process. The proposed changes would “greatly (affect) innovations and public health in California,” argued the California Healthcare Institute. No one asked CHI, but I assume they believe the changes would impact the same innovation from sea to shining sea (not forgetting Alaska and Hawaii).

Taking the broader geographical view, the Advanced Medical Technology Association (AdvaMed) hedged its bet a bit by urging the agency to keep on keeping on with its proposed changes to the premarket review program for low- and moderate-risk medical devices by building on what’s already there. AdvaMed then went on to say it was worried by the breadth of FDA’s proposals for change. They also said the FDA moves could stifle innovation.

AdvaMed advised the FDA to focus on areas where there is general consensus, such as increased reviewer training, development of more specific guidance documents to give industry a clearer picture of expectations, and improvements to the review pathway system.

The 510(k) process is the clearance mechanism by which the vast majority of such medical technologies are brought to market, CHI notes. In the last year alone, 3,000 new devices were cleared under the 510(k) process. It is a long-standing, proven mechanism that allows medical device developers to bring new products to market based on data on existing devices, known as predicates, that have already been proven safe and effective, CHI adds.

In comments submitted to FDA in response to the agency’s release in August of more than 60 proposals to change the 510(k) process, AdvaMed said that instead of implementing an extensive list of potentially disruptive proposals, FDA should focus on the proposals the agency has advanced that enjoy broad agreement, such as: increased reviewer training, development of specific guidance documents, and improvements to the de novo review pathway.

CHI:  “We agree that regulatory improvements can and should be made to increase efficiency, predictability and consistency of the 510(k) clearance process. However, we are particularly concerned that a number of the proposals on the table may result in a slowdown in innovation, which would lead to job loss and fewer innovations for the patients who need them.” In addition to filing its comments, CHI joined with LifeScience Alley, the Medical Imaging and Technology Alliance (MITA) and the Medical Device Manufacturers Association (MDMA) to submit a complementary set of points. This joint effort recognizes the importance of the 510(k) system to the future of medical technology innovation across the country.

By working together, MITA says it believes a reformed clearance process can be adopted that promotes innovation, enhances regulatory predictability, improves patient safety and protects public health.

MITA believes it is important for the FDA to provide additional detail about the provisions in order to adequately assess their impact and urges prioritization of the broad scope of proposed changes. Additionally, MITA encourages the FDA to allow stakeholders sufficient time to thoroughly evaluate and respond to each specific proposal through public comment opportunities and in-person meetings.

It’s worth noting that groups like AdvaMed and MITA have to be cautious in their criticism of FDA. It’s a little like doing a big public harangue against the IRS, and then wondering why you got audited. But knee-device maker ReGen was apparently angry enough over the FDA’s decision to rescind its 510(k) approval to go public. Very public. In their own statements and in extensive media coverage in the Wall Street Journal and elsewhere, they made it clear they think recent FDA actions are driven by politics, not good policy.

As reported in the Journal, a “political agenda” is driving the agency’s moves against ReGen’s knee device, called Menaflex, according to CEO Gerald Bisbee. “The agency’s clearance of Menaflex has become a political football and the FDA is not playing by the rules,” he said.

Not surprisingly, FDA disagrees, saying its actions were good policy that “send the right message” to the device industry.

CHI’s more sedate comments, submitted to the FDA’s Center for Devices and Radiological Health (CDRH), came in advance of CDRH Director Dr. Jeffrey Shuren’s scheduled town hall meeting in Irvine, Calif. on Oct. 7, a critical chance for industry and patients to express their ideas for regulatory reform that will promote investment, innovation and job creation in the state of California. Shuren’s visit to Irvine marks the last of three CDRH Town Hall Meetings held this fiscal year.

Other locations included Bloomington, Minn. and Boston.