On Jan. 15, 2021, the U.S. Department of Health & Human Services (HHS) issued a notice, “Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements.” With this notice, HHS provided an overview of data collected on medical device adverse events. HHS immediately exempted certain medical devices from the requirement to obtain premarket clearance. This shift in policy shows that HHS may make certain temporary policies providing regulatory flexibility during COVID-19 permanent in the coming months.
Background on the Regulation of Medical Devices
Medical devices are categorized based on the risk they pose to the public. Class I devices, products “that present no unreasonable risk of illness or injury,” are subject to general controls. Class II devices are “potentially more harmful” than Class I devices and “must comply with federal performance regulations known as ‘special controls.’” Class III devices carry the highest risk, in that they are for “use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.”
Class III devices require a premarket approval (PMA). A PMA is the most stringent type of premarket submission and requires the sponsor to provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use. Some Class I and most Class II devices require a premarket notification known as a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics and performance testing. Select Class I and II medical devices are considered 510(k) exempt, which means that no premarket notification or approval is required. A device can be deemed 510(k) exempt if HHS determines that such notification is not required to assure the safety and effectiveness of the device.
Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency
In order to ensure the availability of medical devices and increase opportunities to remotely monitor patients to facilitate telemedicine and social distancing, the Food and Drug Administration (FDA) issued temporary enforcement policies which generally provided that the FDA does not intend to object to the distribution and use of certain medical devices that were not currently FDA cleared. The FDA provided such flexibilities in the following list of guidance documents:
FDA Review of Adverse Event Data
The FDA conducted a data-driven review to determine whether a temporary waiver of the section 510(k) premarket notification requirement for some devices during COVID-19 should be made permanent. To do so, the FDA reviewed the publicly available adverse event reporting database called the Manufacturer and User Facility Device Experience database, or MAUDE. Specifically, the FDA reviewed data in MAUDE for a 10-year period: Nov. 1, 2010, to Nov. 30, 2020. The data was reviewed and categorized based on whether the data was collected pre-COVID-19 or after the beginning of the public health emergency caused by COVID-19. A detailed data analysis can be found in the notice.
Making Temporary Policies Permanent
Based on the FDA’s review of adverse event data associated with medical devices for which regulatory flexibilities were granted due to COVID-19, the FDA immediately exempted seven Class I devices from the 510(k) premarket notification requirements. All the exempted Class I devices are some form of medical glove. According to the FDA, “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 these [C]lass I devices.” Additionally, the FDA is proposing to exempt an additional 84 devices from the 510(k) premarket notification requirement, subject to a 60-day public comment period. Select medical devices that the FDA is proposing to exempt from the 510(k) premarket notification requirement include: the N95 respirator with antimicrobial/antiviral agent for use by the general public in public health medical emergencies, a surgical mask with antimicrobial/antiviral agent, the N95 respirator with antimicrobial/antiviral agent and electrocardiograph software for over-the-counter use.
This is the first of what could be many examples of temporary policies intended to cut regulatory red tape during COVID-19 becoming permanent policies moving forward.
