Data Don't Support Breakthrough for 510(k)s: Attorney

Attorney and data scientist Bradley Thompson (Epstein Becker Green) says his review of data on breakthrough device designation for 510(k)s indicates the process is not likely to be helpful for those devices. Writing in his firm’s Health Law Advisor, Thompson says that when he works with medical device companies, his goal is to have as little interaction with FDA as possible, rather than the increased agency attention the designation offers.

“FDA is not a taxpayer-subsidized consulting organization,” he explains. “They are a regulatory body whose mission is to protect patients. They are a law enforcement agency. They are not trained in constructive problem-solving of the type that a consultant would do. That’s not a criticism. In my opinion, FDA is very good at what it does: regulating.”

Thompson points out there is a bit of an inherent conflict between the mission of protecting patients and the objective of finding or discovering the least burdensome pathway through the agency.

When he looked at FDA data on breakthrough device designations, Thompson found that while the agency has made over 600 designations, it has released only 44 marketing authorizations for those devices. He also found that:

• for those breakthrough devices submitted through the 510(k) process, the breakthrough devices took three days longer to be cleared than comparable devices that were not in the designation category; and
• for those breakthrough devices submitted through the de novo process, the breakthrough devices received a final decision 75 days quicker than the average for all products submitted through the de novo pathway.

“On the whole,” Thompson concludes, “acknowledging the limitations such as the high degree of variability, small data size, the lack of any way to review the [agency’s] claim that the development process is faster, I would have to seriously question the value of the breakthrough device designation for devices that qualify for a 510(k). If I were going to take the risk that FDA would tell me to develop much more expensive data than I had planned for a breakthrough device, I would want at least a more compelling case that the review time should be shorter for those that qualify. On the other hand, for devices that need to go through the de novo process, I do think the data support the value of obtaining the breakthrough device designation. While a quick review certainly is not a foregone conclusion given the variability of the data, on average it seems like a good bet.”