FDA device regulator calls for more authority

Without specifically endorsing legislation introduced by House Democrats, the FDA's top dog on medical devices has thrown his support behind tougher regulations for approving products that have designs traceable to recalled items.

It is the kind of authority that might have kept vaginal mesh products and problematic hip joint replacements made by Johnson & Johnson ($JNJ) and others from wreaking the medical and legal havoc they have. Not surprisingly, the industry's response is the FDA has all the rules and regulations it needs.

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, told Bloomberg that under current rules, a manufacturer can voluntarily pull a device with design flaws and resubmit another version. The FDA must approve without human testing devices that have an eligible "predicate" unless the older device was ordered by the agency or a court to be pulled.

That is what happened with vaginal mesh products that have since failed, resulting in hundreds of lawsuits. A report by the FDA released in July found deaths related to the products have increased 5-fold.

House Democrats have introduced legislation that would close what Shuren referred to as the "loophole." The Advanced Medical Technology Association maintains devicemakers already labor under a long and difficult approval process, and the additional authority would only add to the burden.

Shuren acknowledged that only an average of 28 of 3,000 devices approved annually can be traced to the loophole. However, a few of those devices, like vaginal mesh, have created out-sized problems that have undermined the public's faith in FDA oversight.

"It's good for patients and it's good for companies and it assures that if there's a problem with the new device, it gets addressed before it goes to market," Shuren told Bloomberg.

- get the Bloomberg story
- here's more from Bloomberg on meshes


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.