HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process.
In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance.
The agency also proposed permanently exempting 84 Class II devices from the clearance review process, including home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns.
The agency said it based its decisions on a review of adverse events reported to its MAUDE database about the types of devices between 2010 and 2020. The devices recommended for permanent exemption accounted for 46 deaths reported to MAUDE, including 16 related to facility-use apnea monitors.
The MAUDE database has long been criticized for inaccuracies and misclassifications of adverse events. FDA watchdog Madris Tomes, CEO of DeviceEvents, told Medical Design & Outsourcing that she has “concerns about these devices being used later as the predicate for other devices. That cycle has been problematic for years, and weakening it further could be detrimental to public health and safety. …
“I think this also would open the door to other companies and signal them that if they don’t report adverse events, that the devices will be cleared,” Tomes added. “I know that there are some new providers in this space — companies that weren’t making medical devices before COVID, who adapted production to now be medical device manufacturers. It is unknown whether they are familiar with post-market surveillance requirements such as how to report adverse events, and I am not certain if they are being inspected. I would feel much more comfortable with the EUA being extended as we continue to struggle with COVID, and still require the formal approval process. I appreciate that they are relying on adverse events, but those are used to signal issues, not to determine if a product is safe.”
HHS noted that exempting these 91 device classes “could eliminate anywhere from $9.1 to $364 million in startup costs if there were one new entrant into each device market. Savings could further accrue based on each new market entrant. Instead of being costs passed along to patients and taxpayers, these savings could be invested in other areas such as research and development and manufacturing.”
President-elect Joe Biden’s administration could rescind the permanent and proposed exemptions.