Medical Devices

Sen. Franken to Shuren: Get industry input before changing 510(k) system

Minnesota Sen. Al Franken is urging the U.S. Food and Drug Administration to include the perspective of medical device manufacturers in his state and around the country before changes are made to the 510(k) approval process.

Franken’s office issued a press release Thursday that said  he has sent a letter to Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, to express his concern that the industry’s voice is not being heard in these discussions to overhaul the 510(k) system. Many believe that the 510(k) review process has been compromised. The FDA is reviewing the system and has asked the Institute of Medicine to provide recommendations.

“I understand that the FDA has asked the Institute of Medicine (IOM) to review the current 510(k) process and specifically to consider several issues relating to the device review and approval process,” the letter  from Franken read.  “I believe that the medical device industry contains a wealth of expertise that is too often neglected when considering changes to the device review process. I strongly encourage you to establish a clear process for soliciting and considering the suggestions and concerns of the medical device industry on any and all recommendations made by the IOM before finalizing or implementing any changes to the process.”

Having the support of the liberal senator has been a boon for the medical device industry, said Mark DuVal, president of DuVal & Associates and an expert on FDA matters, in a recent workshop he conducted about the 510(k) process. That has bolstered the argument of the medical device industry that also enjoys support of the rest of Minnesota’s congressional delegation.


On Thursday,  in an email sent to clients of the firm, a colleague of DuVal’s cheered this development.

“It excites us to see the continuing advocacy of our Minnesota Congressional delegation,” wrote Mark Gardner, associate attorney at DuVal & Associates.

No comments