FDA announces changes to common review process for medical devices

The Food and Drug Administration on Wednesday announced that it will be making 25 changes this year to its most commonly used approval process for medical devices. The proposal drew immediate praise from the device industry and scorn from some consumer advocates.

Key actions include: 

• Streamlining the review process for certain innovative, lower-risk devices;

• Clarifying when clinical data needs to be submitted; and 

• Establishing a new Center Science Council of senior FDA experts.

"These actions are intended to foster medical device innovation and support the safety and effectiveness of medical technologies in the United States," Jeffrey Shuren, director of the Center for Devices and Radiological Health at FDA, said in a conference call with reporters.

The expedited approval pathway for low-risk devices such as catheters and diagnostic imaging devices was created about 30 years ago, and is used to approve about 3,000 new medical devices each year.

FDA launched a review of the so-called 510(K) process 16 months ago following growing criticism that it is failing both the industry and consumers. Two working groups issued 55 recommendations in August, and the 25 actions announced Wednesday take those into account along with dozens of public comments.

"We have been hearing major concerns about the program from industry, consumers, healthcare professionals and others," Shuren said. "While industry has said the program has become unpredictable, inconsistent and opaque and is stifling innovation, consumers, third-party payers and some healthcare professionals have said the program isn't sufficiently robust to ensure the safety and effectiveness of some devices it covers."

The medical device industry praised the report.

"The plan is clearly a good first step that will address some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the de novo process," Stephen Ubl, president and CEO of the Advanced Medical Technology Association, said in a statement. "In addition, FDA's plan drops or defers for IOM review many proposals that would have significantly slowed patient access to new diagnostics and treatments and placed significant burdens on industry without corresponding health benefits."

The "critical next step," Ubl added, "is how FDA implements the plan through guidances [sic] and regulations. Those details will determine whether today's proposed changes will improve patient access and American competitiveness."

The consumer advocacy group Public Citizen, however, said FDA "dodges responsibility" by deferring several recommendations to a future report by the Institute of Medicine. Public Citizen believes the device industry abuses the 510(K) process by using it to get approval for devices that pose "substantial risks" such as implantable, life-supporting or life-sustaining devices.

The consumer advocacy group criticized FDA for putting off the creation of a new, more stringent category requiring clinical data. The group also criticized deferred action on:

• Defining the scope and grounds for rescinding a 510(k) device clearance (currently, such authority is lacking);

• Seeking more authority to require post-marketing studies as a condition of approval; and

• Clarifying when a device should no longer be available as a predicate for a subsequent 510(k) device application.


—This post was updated at 5:30 p.m. with Public Citizen's comments