The range of devices eligible for the FDA breakthrough devices program is presumed to be wide and to include both diagnostic and therapeutic devices. But Maureen Dreher, a policy analyst at the Office of Device Evaluation, told attendees on a recent FDA webinar that devices designed to ward off a disease or condition may or may not qualify for the program.
The FDA breakthrough devices program, which essentially builds on previous programs of the same intent, was put into place via the 21st Century Cures Act to provide a more expeditious review process for devices and diagnostics that treat deadly or debilitating diseases. The agency published the final guidance for the program in December 2018, noting that products reviewed under a biologics license application would not be eligible for the breakthrough devices scheme. There were some concerns from industry regarding the timelines spelled out in the draft, however, a concern that was not always addressed to industry's satisfaction. (See BioWorld MedTech, Dec. 19, 2018.)
One of the attendees on the Jan. 17 webinar posed the question regarding devices designed to serve a prophylactic purpose, and Dreher was reluctant to offer a hard-and-fast answer. "The bottom line is if you have a device that is operating more in a preventive manner, it's worth reaching out to us" about that device for the breakthrough program. "A lot of what we do in making that call . . . is linked very closely to how the device is being used and what the intent is," she said, adding that such a device is "something that's worth a conversation ahead of time" rather than going too far into full development process on the basis of a presumed yes-or-no answer.
Dreher said a prevention device could qualify as a treatment device, but the method of prevention and the condition or disease it prevents will have a lot to say about whether the agency sees the application as appropriate for the breakthrough program.
DDPs not mandatory
A common question is whether program features, such as data development protocols (DDPs), are mandatory. Dreher said, "the simple answer is these are not required steps . . . once you've received a designation," she said, "you can pick and choose from them depending on what stage of development" the device is, among other considerations.
Dreher said that while the DDP option as spelled out in the final guidance is not mandatory, the clinical protocol agreement is very nearly so. "You can submit DDP requests and a separate request for a clinical protocol agreement," she said, adding that the DDP is more of a high-level discussion of the main elements of the study, but both are appropriate for obtaining feedback. A DDP is a higher-level mechanism and is not legally binding, while the clinical protocol agreement is.
Dreher said those doing the breakthrough devices program administrative work are not usually involved in the review of the application, but may consult with the lead reviewer for that application. She said also a sponsor may receive a letter requesting additional information or something related to a perceived deficiency in the application, which is due from the agency by day 30.
However, Dreher emphasized that "sending that letter does not stop the review clock. As a sponsor, you have to respond pretty quickly" in order for the FDA to meet the statutory deadline of responding to a request for entry into the program by 60 days. Sponsors should directly contact the lead reviewer to discuss a deficiency or the request for additional information rather than program administrative staff as this will hasten the agency's response.
Dreher said the agency's breakthrough mailbox is open during the partial government shutdown, and the FDA is processing requests for entry into the breakthrough program as well. The FDA will continue to hold entries confidential, although the agency will publish the number of applications that have made it into the breakthrough program.
Dreher said the FDA is internally tracking metrics, such as numbers denied, total time to decision, and number of substantive interactions. While the agency has not made a decision on whether to publish such information, she said, "it's good to know there's external support for that sort of information" being released for public scrutiny.
The first criterion for entry into the breakthrough devices program includes that the applicant device deal with life-threatening diseases or conditions, but Dreher said "we don't necessarily prioritize the review or designation decisions based on the mortality rate" of that target indication.