Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process.
HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes 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 notice was published on Jan. 15, 2021, in the Federal Register.
HHS said it based its decisions on which devices to consider exempting on a 10-year review of adverse events reported to its MAUDE database. 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.
The American College of Radiology, the Radiological Society of North America and the Society for Imaging Informatics in Medicine collectively objected to the proposed changes, which would affect several products used in radiology, including artificial intelligence (AI) and machine learning (ML) software. Making the temporary policies permanent would create a “gap in oversight” that could harm patients and providers and potentially be counterproductive for the new and burgeoning AI imaging market, they said.
The American Society of Anesthesiologists also objected to the move toward deregulation of AI and machine learning software, saying that ML software trained on data that omits certain patient populations could cause harm. The group also cautioned against overreliance on postmarket and adverse event data. Historically, the FDA has had trouble enforcing postmarket data requirements, partially because companies have had difficulty with patients who fail to follow through.
The Medical Imaging & Technology Alliance said it had previously asked for more clarity to help medical imaging device manufacturers to navigate their regulatory responsibilities for products cleared under relaxed guidance put in place for the COVID-19 public health emergency. Instead, the proposal “has created confusion” about those responsibilities and “may erode the public’s confidence in the safety and efficacy of the devices in question,” the organization said.
The American Medical Association also objected, asking HHS to continue to let the FDA make science-based decisions on “the appropriateness of exemptions for certain medical devices from premarket review requirements.”
Medical device companies were slightly more mixed in their comments:
- Baxter said it wants continued 510(k) review of infusion pump safety management software but would appreciate some efficiencies in the process.
- Caption Health, which develops AI-guided ultrasound software, “strongly” opposed making the proposal permanent, citing overreliance on adverse event reports. Caption joined others in noting that the absence of such reports is not a reason to stop regulating the devices but an indication that agency oversight is effective.
- Dr. David Albert, chief medical officer of AliveCor, wrote to object to the permanent exemption of electrocardiograph software for over-the-counter use, citing patient safety risk.
- Drug company Roche came out in favor of the proposed changes related to certain digital pathology devices, noting the low numbers of adverse events associated with them in the FDA’s MAUDE database. So did the Mayo Clinic.
HHS also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance. The agency noted in January 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 Biden’s administration could rescind the permanent and proposed exemptions.