FDA Plans to Improve Review Path for Medical Devices

The FDA this week outlined a plan to improve the path to market for medical devices, including streamlining the review for low-risk devices and clarifying when clinical data should be submitted.

The 25 actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health (CDRH), said in a statement.

Manufactures of lower-risk medical products, such as diagnostic imaging devices, must provide the FDA with a premarket notification submission, known as the 510(k). This must demonstrate that the product is “substantially equivalent to another, legally marketed medical device that is also lower-risk,” according to the FDA.

The plan release comes after the CDRH set up working groups in September 2009 to address concerns about this process, which critics said was unpredictable and inconsistent or not sufficiently robust, the FDA said. Based on public input, the groups released recommendations last August.

“After reviewing public comment, CDRH now intends to take 25 actions to improve the 510(k) program in 2011, including new guidance and enhanced staff training,” the agency said in a statement.

The FDA is deferring some of the contentious decisions, giving the Institute of Medicine a chance to provide feedback on seven recommendations, including the creation of a new class of devices requiring more data for approval and authority to require postmarket surveillance studies as a condition of clearance for certain devices. The FDA is also planning for a public meeting in April for feedback on two other recommendations. The device industry had expressed concerns that the FDA’s plan would slow the development of new products.

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed) called the plan “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.”

Ubl said in a statement that AdvaMed was pleased with FDA’s analysis of industry comments, and that the 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 is how FDA implements the plan through guidances and regulations,” Ubl said. “Those details will determine whether today’s proposed changes will improve patient access and American competitiveness.”

The Medical Imaging and Technology Alliance (MITA) also welcomed the FDA’s plans for to provide clear timelines and a more predictable process, and said they were encouraged by the delay in some of the controversial items.

“A clear, transparent, and timely 510(k) clearance process is critical to ensuring that Americans have access to the most advanced, life-saving medical technology innovations in the world,” said Dave Fisher, executive director of MITA, said in a statement.