The Department of Health and Human Services on Friday announced a rule that would make permanent an originally temporary waiver of premarket review requirements for certain medical devices under the Food, Drug, and Cosmetic (FDC) Act during the Food and Drug Administration’s (FDA) initial response to the COVID-19 pandemic.
In March 2020, the FDA began issuing guidance to make more flexible the process of meeting the progressive demand for personal protective equipment, disinfectant products, and other related items necessary for the pandemic response. Among the guidance issued were flexibilities for distributing and using medical devices that had not yet reached 501(k) clearance, a type of premarket review used to approve devices “substantially equivalent” to devices already legally marketed.
The devices in question include one unclassified and 83 class-II devices — among them are a ventilator, sterilizer, air purifier, and N95 mask. There were seven class-I devices included in the original public health response waiver that already were approved for a permanent waiver of 501(k) — among these are different types of medical gloves. Under the FDC Act, class-I devices “present no unreasonable risk of illness or injury,” class-II devices are “potentially more harmful” and “must comply with federal performance regulations known as ‘special controls,’ ” according to the proposal.
According to the FDC Act, the HHS secretary may exempt medical devices from 501(k) “if the Secretary determines that such a report is not necessary to assure the safety and effectiveness of the device.” With this in mind, the FDA ran studies to test adverse effects due to the use of various medical devices determined to be of higher demand during the pandemic and found that the seven and 84 aforementioned class-I and class-II/unclassified devices, respectively, no longer need the premarket notification to be assured that these devices are safe and efficacious, according to the proposal.
Waiving the 501(k) requirement for these devices, an “expensive and time-consuming” process, “could eliminate anywhere from $9.1 to $364 million in startup costs if there were one new entrant into each device market,” benefiting taxpayers, the proposal argues. Patients also “stand to gain more immediate access to new products that would otherwise be required to obtain a 510(k) clearance prior to marketing” with the requirement waiver, and the FDA would be able to conserve its “scarce review resources” and channel them into reviewing other innovative technologies aimed at curbing COVID-19’s impacts.
The HHS is requesting public comment on the proposed inclusion of the 84 class-II/unclassified devices.