Cracks in the Food and Drug Administration's (FDA) approval process for medical devices allows "potentially ineffective" products to make it to market, the consumer group Public Citizen writes in the latest issue of PLoS (Public Library of Science) Medicine. The article says approval rules are too lax, contain loopholes and are inadequately enforced.
The authors raise concerns with the premarket notification, or 510(k), process, under which device makers can secure expedited approval if they can show that their device is "substantially equivalent" to a device that's already on the market. Some lawmakers — in particular, Sen. Chuck Grassley (R-Iowa) — have pressed for tougher standards for the expedited procedure.
The authors outline eight weaknesses in the approval process, including:
* A lower approval standard for devices than for drugs;
* Lax interpretation of the requirements for the 510(k) pathway;
* A loophole that allows manufacturers of novel devices to circumvent the more burdensome pathway for new devices;
* Failure of the FDA to appropriately regulate many types of devices that were first marketed prior to the 1976 enactment of the current regulatory scheme; and
* A superfluous appeal mechanism that gives manufacturers a second go for approval after FDA has rejected a device.
In addition, the authors write, manufacturers can challenge FDA requests it considers onerous while fees paid by the medical device industry for FDA reviews make the agency beholden to the industry it is supposed to regulate.
The authors call for a multi-tiered fix combining legislation, regulation and changes in agency practice.