FDA Guidance Seeks to Get Technology to Patients Faster


Posted October 24, 2017

In an effort to speed up the development and review of innovative medical devices, the Food and Drug Administration has issued draft guidance outlining a new Breakthrough Devices Program.

This program, which was established through the 21st Century Cures Act passed by Congress last year, is intended to “help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives,” the agency said in an email to stakeholders.

To provide this more timely access, the FDA guidance stipulates that breakthrough device submissions will receive priority review status, meaning that these submissions will be “placed at the top of the appropriate review queue and receive additional review resources, as needed.” The agency also intends to “provide interactive and timely communication with the sponsor during device development and throughout the review process.”

“Earlier and more frequent interaction between the FDA and manufacturers … should allow manufacturers to make the best use of their resources to bring state-of-the-art medical technologies to the market faster,” FDA Commissioner Scott Gottlieb said in a statement.

The draft guidance also notes that the FDA plans to leverage postmarket data collection, “when scientifically appropriate,” to help speed up and streamline device development and review.

“We may not have definitive answers to all questions relating to the benefits and risks of the device at the time of approval because the time and cost of such data collection would adversely affect public health,” the FDA wrote. “FDA may accept a greater degree of uncertainty of the benefit–risk profile for these devices if the uncertainty is sufficiently balanced by other factors, including the probable benefits for patients to have earlier access to the device.”

This draft was one of three guidance documents released on Oct. 24 that the agency hopes will “make the development process more efficient and predictable.” The other two documents presented final guidance on when manufacturers need to submit a new 510(k) prior to making a change to an existing device, including software changes.

“These are just some of the steps we’re taking to encourage innovation in medical devices,” Gottlieb said. “The FDA will be unveiling additional steps we’ll take to improve the path for device innovation while building additional safeguards to ensure the safety and effectiveness of new and existing products.”

Comments on the draft Breakthrough Devices Program guidance can be submitted via www.regulations.gov until Dec. 26.