FDA issues new plan for medical devices

The US Food and Drug Administration (FDA) has issued an action plan listing 25 steps it intends to take this calendar year to make the path to market more efficient for medical devices. The plan includes an overhaul of the agency's process surrounding 510(k) submissions for lower-risk medical devices, which the industry has long argued is unpredictable and inefficient.

The process requires manufacturers hoping to market lower-risk devices to submit a premarket notification to the FDA demonstrating that their device is basically equivalent to some other lower-risk device already on the US market. Industry has complained that, among other deficiencies, the process leaves it unclear when clinical data needs to be submitted for a device, while consumer groups worry that the premarket standards aren't high enough.

The measures planned for 2011 include new guidance on topics such as the need for clinical data, as well as enhanced staff training at the agency. The FDA also intends to establish a Center Science Council of senior FDA experts "to assure timely and consistent science-based decision-making."

In 2009, the FDA established internal working groups to evaluate the review process and also asked the independent, nonprofit Institute of Medicine (IOM) to make recommendations for improvement. The IOM's review is still underway, but the internal working groups issued a list of 55 recommendations in August 2010 from which the 25 steps now being announced were culled.

The FDA said a group of seven of the recommendations that have been particularly controversial will not be considered final until the IOM has weighed in on them. These include plans for the agency to seek greater authority to require postmarket surveillance studies as a condition of premarket approval and to consider off-label use when determining the intended use of a device.

Stephen J Ubl, president and CEO of the Advanced Medical Technology Association, called the new plan "a good first step" and said his group is pleased 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 Medical Device Manufacturers Association issued a statement commending the FDA's "open and constructive process to develop consensus" surrounding the proposals. "However, we remain concerned that FDA has deferred final decisions on key issues to the Institute of Medicine,” said Mark Leahey, the group's president and CEO.

"Numerous stakeholders have expressed concerns with these proposals due to the adverse impact they would have on innovation, patient care and job-creation."