FDA Issues “Breakthrough Devices” Guidance

The FDA released three new guidance documents on October 24, 2017 for medical devices to “improve clarity” over the agency’s approval and clearance process.

The first, a draft guidance, relates to the agency’s “Breakthrough Devices Program,” which includes an Expedited Access Pathway (EAP) program designed to allow patients to quickly access technologies that have no alternative or that offer a significant advantage over FDA-cleared or approved alternatives. The program would enable a more “agile” pre-submission process for breakthrough devices.

Another two final guidances are designed to help innovators determine when they need to submit a new 510(k) prior to making a change to a device subject to premarket notification requirements. The agency says these policies will help those innovators introduce iterative improvements that can improve a product’s safety and performance by establishing a “brighter line regarding when the FDA needs to review and clear these changes in advance.”

Under current rules devices granted priority review are placed at the top of the review queue and are assigned additional review resources but are not guaranteed a faster review. Breakthrough devices may take longer to review than other devices due to novel scientific issues.

For clinical trials for breakthrough devices, the agency says it will consider certain clinical study features to ensure “efficient and flexible” studies, including:

• Prespecified endpoints regarding the minimum clinically meaningful impact;
• Intermediate and surrogate endpoints where evidence is provided to support the endpoint as reasonably likely to predict the clinical benefit of a device;
• Composite endpoints with an explicit rationale for the meaningful effect size; and
• Phased study design

The Regulatory Affairs Profession Society (RAPS) reports that once a device has been designated as a breakthrough device, sponsors can select one or more features of the breakthrough program for additional interactions with the agency.

Sponsors can request to have “sprint” discussions with FDA on novel issues related to their device, with the goal of reaching mutual agreement with the agency within a set time period. FDA says that sprint discussions should focus on a single topic and follow a defined schedule.

Scott Gottlieb, M.D., the agency’s new head said these guidances will make the regulatory process more efficient and predictable by measuring outcomes relevant to regulatory decisions. He said these tools can also “help minimize the use of animal studies, reduce the duration of testing, or require fewer patients in a study by optimizing patient selection or improving on the ability to measure benefit and risk through the availability of measurements that are more sensitive for assessing these outcomes.”

To read and comment on the draft guidance, click here.

You have until Christmas to submit your comments.