New Program Could Halve PMA Processing Time for Innovative Devices

In an effort to foster development of cutting-edge medical device technologies, the US FDA has proposed a new program, the Innovation Pathway, to prioritize and potentially expedite reviews of breakthrough devices.

Under the new program, the FDA could begin premarket reviews of qualifying devices within 150 days, half the time it now takes the agency to process premarket approval applications. In order to participate in the Innovation Pathway program, a device must include technology considered “truly pioneering” and able to revolutionize health care delivery. The manufacturer must be able to meet development roadmaps and timelines set by the Center for Devices and Radiological Health (CDRH); qualifying devices would also be assigned case managers and possibly be allowed more flexible clinical trial protocols.

Major features of the Innovation Pathway will include a voluntary third-party certification program for US medical device test centers, a core curriculum available to the public for medical device development and testing, and greater use of data and experience gathered in other countries.

Another component of the program—“formal horizon scanning”—entails the CDRH systematically monitoring literature and funding in order to predict new medical device technology developments.

A new oversight entity, the Center Science Council, is currently being formed to review Innovation Pathway applications.

The Innovation Pathway’s pilot submission, a brain-controlled prosthetic device developed by the Defense Advanced Research Projects Agency (DARPA), has been announced along with the program’s rollout. Manufacturers of high-risk or novel devices will no doubt monitor the pilot to gauge whether the new program does indeed prove more efficient than current the current PMA process.

The CDRH has begun soliciting public comment on the Innovation Pathway program, and plans a March 15 public meeting on the topic.

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