Inside Health Reform Quotes Nathan Brown on Impact of New Medical Device Laws

Nathan Brown, a partner in the health practice at Akin Gump, was quoted by Inside Health Reform in the article “Industry Sees Culture Change At FDA’s Device Center, Precipitated By New Laws.” The publication reports that new legislation has led to a buoyant mood within the medical device industry, with many praising the Food and Drug Administration for what they see as a culture change.

According to Brown, “We’ve had a blizzard of laws and keeping up is challenging. It has been an extraordinarily busy time mirrored by changes in medical device technology.” This includes the revised process for de novo submissions—meant for devices that are not high-risk and have not been previously classified—that is now more predictable for companies.

Brown also noted the Medical Drug User Fee Amendments (MDUFA IV) commitment letter commits FDA to issuing a decision on 50 percent of submissions in 2018 and 70 percent in 2022. FDA will also issue guidance that includes a submission checklist to make the process more timely and efficient, he noted.

For certain qualifying medical devices, Brown said, manufacturers will only be required to report malfunctions on a quarterly basis rather than reporting a malfunction each time one occurs. Such a move will eliminate what he described as an inefficient use of resources for both businesses and FDA, particularly since many of those reports “aren’t really giving new information.”