Photonics- and optics-based biomedical device innovators, take note: A new U.S. Food and Drug Administration (FDA) program mandated by the 21st Century Cures Act offers a huge opportunity for emerging technologies. In late October 2017, ahead of schedule, FDA announced the Breakthrough Devices Program (BDP), which supersedes and combines several of the agency's existing programs to speed patient access to novel devices. In a nutshell, the BDP creates a more agile pre-submission process.
Bio-optical and photonics-based devices that promise significant benefit over current standards of care have tremendous potential. And early-stage companies are particularly primed to gain. But don't delay if you're interested, because the comment period for the draft guidance ends December 26, 2017.
Guaranteed priority status
"This program has the potential to be very helpful. There is no downside," says Allyson Mullen, an attorney specializing in medical devices with Hyman, Phelps & McNamara in Washington, DC. She urges developers to "definitely take advantage [of the program]" because the BDP will provide companies with "early and potentially frequent interaction with the agency that can help prevent challenges later on during the review process."
In addition, all devices designated as breakthrough technologies are guaranteed priority review status. Eligible devices include all those subject to FDA's premarket approval, de novo, and 510(k) reviews. With the BDP, FDA expects patients will more quickly gain access to certain devices that more effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions. These particular technologies have no alternative or offer a significant advantage over FDA-cleared or approved alternatives.
All companies can benefit from increased interaction with FDA prior to and during device submission but Mullen says very early stage companies, in particular, will find the BDP attractive. She notes that the breakthrough designation can be helpful when trying to attract investors because it shows the agency’s high level of interest in a device.
According to the FDA's draft guidance describing the BDP, FDA personnel reviewing breakthrough devices will receive additional training—though the guidance does not specify the exact type of technical training. Despite the lack of detail, the fact that FDA promises opportunities to keep up with rapidly changing emerging technologies is positive. This kind of proactive training was missing just a decade ago.
In the past, FDA has tried a number of different programs to push emerging technologies through more quickly, the most successful of which was the most recent—the Expedited Access Pathway. In early November 2017, FDA granted Second Sight Medical an EAP designation for its Orion Cortical Visual Prosthesis System. Orion converts images captured by a miniature video camera mounted on a patient's glasses into a series of small electrical pulses. An electrode array implanted on the visual cortex surface detects the pulses; the intended result is the perception of light patterns.
FDA has indicated that EAP designations will convert to breakthrough device designations when the guidance document is finalized.