FDA has withdrawn a Trump-era proposal to exempt some devices from 510(k) requirements after finding "the proposed exemptions and bases for them are flawed."
The proposal, which HHS made in the final days of the Trump administration, received strong pushback from Baxter and digital health startups, among others. FDA's withdrawal notice on Friday echoes elements of the industry feedback, including criticism of the reliance on the agency's Manufacturer and User Facility Device Experience (MAUDE) database.
HHS never consulted FDA or notified it of the plan prior to publishing the Jan. 15 proposal, according to the withdrawal document, resulting in text the agency said lacked "scientific support" and contained "errors and ambiguities."
The HHS proposal was underpinned by the number of adverse events related to certain types of medical devices in the MAUDE database. By looking at the numbers of adverse event reports logged before and after emergency exemptions were put in place in response to COVID-19, HHS argued it could safely eliminate 510(k) requirements and thereby save the industry time and money.
Many developers of the 83 Class II devices and one unclassified device covered by the exemptions took a different view. Pear Therapeutics, for example, said the proposal "endangers public health" and was "issued in a haphazard manner."
The American College of Radiology, Radiological Society of North America, and Society for Imaging Informatics in Medicine sent a letter to HHS last month expressing their concerns about the proposed deregulation of AI/machine learning-enabled software. The groups warned that the list of Class II devices in the proposal included several radiology products and that the "described approach would undermine FDA's critical role in providing reasonable assurance of the safety and effectiveness of radiology software used in patient care."
FDA began reviewing the notice after HHS "received dozens of inquiries" and "staff and leadership" at the Center for Devices and Radiological Health identified issues with the proposal. The feedback from CDRH officials after the publication lends credence to the fact that HHS never consulted with FDA or notified it of the plan prior to publishing the January 15 proposal.
"We did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing the Notice," FDA wrote. "It is particularly important that FDA have at least some level of involvement in this type of an action given the expertise needed in evaluating whether a submission under 510(k) of the FD&C Act is necessary to assure the safety and effectiveness of a device."
In reviewing the notice, FDA, echoing the concerns of organizations including the Medical Imaging & Technology Alliance, found fault with HHS' use of MAUDE data as the sole determinant of whether a device was exempt from 510(k) requirements.
FDA said MAUDE can contain "incomplete, inaccurate, untimely, unverified or biased data," adding that "the incidence or prevalence of an event cannot be determined from adverse event reports alone, due to underreporting of events, inaccuracies in reports, lack of verification that the device caused the reported event and lack of information about frequency of device use."
The agency factors other data, such as recall information, into its decisions about 510(k) exemptions. A broader dataset is needed to capture problems outside the scope of MAUDE, such as performance failings that cause devices to deliver inaccurate readings. Such failings can "contribute to erroneous clinical and surgical decisions," FDA wrote, but may not be apparent in MAUDE.
FDA was critical of how the MAUDE data were analyzed, too, noting that 50 exemptions were based solely on the lack of death-related adverse events. Focusing on death overlooked other significant but not-fatal adverse events. FDA said MAUDE linked one exempted device to 13 malfunctions and 52 injuries.