Nathan Brown Quoted by Medtech Insight on FDA Proposal for Expedited Pathway for Software
Akin Gump health partner Nathan Brown has been quoted in the Medtech Insight article “Software Fast Track? US FDA Asks Developers To Envision ‘Precheck’ Program,” which includes remarks he made at the recent Digital Medtech Conference. FDA Precheck, the article reports, is a concept proposed by the Food and Drug Administration to speed up the path of medical device software products to market, possibly by relying on a company’s track record to expedite regulatory checks.
Brown said there could be some negative regulatory implications from such a program. “For a PMA [pre-market approval] device you have certain benefits for preemption [from personal injury suits], that you wouldn't inadvertently want to lose,” he warned.
Brown also noted that, if the Precheck system were to be based on a company’s track record, there should be considerations for when a mistake occurs by accident without these considerations leading to an automatic loss of the trust FDA has instilled in them.
Finally, Brown pointed to the provisions in the latest device user-fee reauthorization agreement that are aimed at reducing reporting requirements for certain device malfunctions that are well known to the agency. He said he could envision a Precheck program where companies that have met certain requirements, rather than reporting well-known malfunctions or adverse effects, instead “focus the energy on the types of events that are unusual, new, the ones that are really affecting safety in a new way.”