The US Food and Drug Administration proposed new rules this week to expedite the approval of new medical devices that diagnose or treat life-threatening diseases, meet unmet health needs or protect national security.

“Now is the time to assure that we have a regulatory pathway to market that will help facilitate the development and assessment of the truly breakthrough technologies,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), told Nature Medicine.

Through the new Innovative Pathway Program, the FDA hopes to cut the time from application to market approval down to less than half a year. To achieve this, the agency plans to advise companies on clinical trial design early in the development process, before devices are tested. Additionally, the FDA is proposing to certify contract testing centers as a way of providing reliable hubs for clinical trials.

The first product under review is a prosthetic arm developed by the US Defense Advanced Research Projects Agency to treat soldiers injured on the battlefield. This device will serve as a pilot for the new program, explains Shuren. “We are not going to accept other applications until we give the public the opportunity to weigh in our proposals and finalize them,” he says.

The new program adds to a growing list of changes in the CDRH. For example, last month the agency announced plans to expedite the approval of generic devices based on existing designs. These measures, FDA executives are hoping, will help quiet the critics who say that the agency’s heightened regulatory scrutiny cripples innovation.

David Nexon, senior executive vice president of the Advanced Medical Technology Association, an association of medical device manufacturers based in Washington DC, is encouraged by the FDA’s newfound flexibility. “The FDA institutionally has really gotten the message that there is a big problem in the [CDRH], and they are really committed to try and solve it,” he says.

Nexon points out, however, that only one to two devices will reportedly be evaluated each year under the new regulatory pathway, so this move alone will have only a minimal impact on the industry. “Unless you can manage the great bolus of devices, it’s not by itself going to be much help in our overall competitiveness,” he says.