HHS, FDA Backtrack From Plan to Deregulate mHealth Devices, Apps

Federal officials are quietly withdrawing a Trump administration plan to end regulatory review of 83 types of mHealth devices, saying the original plan was flawed and could have put the lives of Americans using that technology in danger.

In a notice posted last week in the Federal Register, the Health and Human Services Department and the Food and Drug Administration announced that they won’t enforce an HHS notice posted on January 15 that, among other things, would have exempted 83 class II devices and one unclassified device from premarket notification. Another 50 devices would have been exempted from review because there had been no reports of deaths associated with their use.

The decision affects dozens of connected health tools, including mHealth apps, smart devices and digital therapeutic services.

Officials said the devices were selected based on a lack of adverse events reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. But just because adverse events aren’t reported, officials said, doesn’t mean they aren’t happening or could happen.

“The January 15, 2021, Notice relied solely upon adverse event reports in MAUDE in determining that a 510(k) is no longer necessary to assure the safety and effectiveness of the devices,” officials said in last week’s filing. “Although adverse event reports are a valuable source of information, the reports have limitations, as noted in the January 15, 2021, Notice, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, 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.”

Officials also noted the number of complaints – both from within HHS and from mHealth and telehealth companies – lodged after the January 15 notice.

“As noted by several commenters, reliance on adverse event reports in MAUDE is an inappropriate basis for exemption because, for example, adverse events may be underreported for certain devices, and a low number of reports in MAUDE may reflect the low number of marketed devices, and not necessarily the risk of injury,” they said. “In addition, relying exclusively on MAUDE data leaves out other important information regarding risk. For example, FDA routinely considers recall information as part of its risk analyses, including for class II 510(k) exemptions.”

In last week’s filing HHS and FDA officials said they found no evidence that HHS consulted with anyone prior to making its announcement on January 15, and that the FDA’s Center for Devices and Radiological Health had issued several objections to the proposed order. In addition, that department and several other commenters noted “various potential errors and ambiguities, such as about mismatched product descriptions, product codes, and regulatory citations.”

“Upon review, HHS and FDA have determined that the proposed exemptions in the January 15, 2021, Notice were published without adequate scientific support, that the Notice contained errors and ambiguities, and that the Notice is otherwise flawed,” the officials concluded.

The issue highlights a long-standing effort to determine how best to regulate mHealth and telemedicine technology, especially as these tools and platforms develop capabilities that not only identify health concerns but support providers in clinical decisions. Left unregulated, apps, wearables and other kinds of technology could harm or even kill the people using them.

Examples of products that fit this category include mHealth apps that assess skin lesions for signs of cancer, wearables that track heart rhythms for evidence of atrial fibrillation, digital health platforms for behavioral health and substance abuse (such as smoking) and smart ventilators designed for home health programs.