Generally, under the 510(k) process, a device that is “substantially equivalent” to another legally marketed predicate device is “cleared” by FDA for legal marketing in the United States. FDA regulations specify the required contents of 510(k) notifications, including labeling, intended use, and clinical and performance data requirements. However, in March and April of last year, in response to the COVID-19 Public Health Emergency (PHE), FDA issued a series of guidance documents designed to provide the private sector with regulatory flexibility to meet the sudden, increased need for personal protective equipment (PPE), disinfectant products, and other devices to combat the pandemic. These guidance documents provided temporary enforcement discretion, announcing that FDA “does not intend to object to the distribution and use” of certain medical devices that were not 510(k) cleared at the time and also, in many cases, providing some exemptions from postmarket compliance requirements such as the Quality System Regulation (QSR).
In May 2020, consistent with Executive Order No. 13924, and Congress' direction in the 21st Century Cures Act, HHS conducted a data-driven review to determine whether temporary waiver of the section 510(k) premarket notification requirement for some devices during the PHE should be made permanent. HHS’s notice says this review concluded that 510(k) premarket notification is unnecessary for several categories of products, including AI imaging devices, due to the infrequency of reports of adverse events.
FDA maintains a publicly available adverse event reporting database called the Manufacturer and User Facility Device Experience database (MAUDE). According to the HHS notice, MAUDE showed a “lack of any adverse event reports in MAUDE” for 83 class II devices and one unclassified medical device listed in the proposal; this list of devices is online here. In addition, there was a “complete lack of or de minimis number of adverse events in MAUDE following FDA's waiver of the premarket notification requirement for the class I devices” listed.
Yet, several medical devices listed in the notice have only begun to be sold in the past few years. In addition, there were new players who introduced devices to the market for the first time in 2020 under COVID-19 enforcement discretion guidance documents and, although FDA requires adverse events to be reported, the agency did not specifically describe for the new players how they should report adverse events until September 9, 2021, at which time FDA required companies to set up an eMDR account. Given the lack of specific agency instruction on how the new device sponsors should report adverse events, and given the complexity of setting up an eMDR account, the validity of basing such a decision on the small number of adverse events in MAUDE is debatable.
Nevertheless, citing the lack of MAUDE reports as its justification, the HHS notice permanently exempts from FDA regulatory requirements seven class I devices for which 510(k) premarket review was temporarily waived during the PHE, all of which are types of gloves. The class 1 device exemptions are immediately-in-effect and not undone by the Biden regulatory freeze.
The notice also proposes to exempt from the 510(k) requirement the additional 83 class II devices and one unclassified device for which premarket review had also been waived during the PHE. This list of devices includes ventilators and PPE, as well as digital devices to manage the safety of drug infusions, monitor fetal heart rates, and deliver behavioral therapy to patients with psychiatric disorders. In addition, the HHS notice calls for a 60-day comment period on plans to permanently exempt other types of products for review.
Despite the industry surprise generated by this notice, it is unlikely the HHS proposal will take effect for the 83 class II devices and one unclassified device. According to the “Regulatory Freeze Pending Review” memorandum issued by the Biden Administration on January 20, the new presidential administration would need to approve this policy for it to take effect, and it is unlikely the new administration will pursue the proposal. We are continuing to actively file 510(k) marketing submissions for many of the device types that the notice proposes to exempt.
Notably, this HHS notice appears to fly in the face of FDA’s new AI device regulation Action Plan, published last week, which specifically called for the creation of an expanded regulatory framework for machine learning devices and for more careful review of products that rely on AI; we analyzed that plan online here.
HHS said in the notice that it is seeking comments on whether premarket review should be permanently waived for the aforementioned devices, and, more broadly, on ways to improve the 510(k) premarket notification program. If you may be interested in submitting a comment, or are interested in more information on FDA’s regulation of medical devices more generally, please contact any of the authors of this alert.
Authored by Kelliann Payne, Jodi K. Scott, John Smith, and Alex Smith