FDA Releases List Of Class I Medical Devices Exempt From 510(k) Notifications
The FDA has compiled a list of over 70 class I medical devices that will no longer be subject to premarket notification requirements, effective immediately. This list’s release comes on the heels of a list of class II device exemptions released last month, and is in accordance with amendments to the Federal Food, Drug and Cosmetic Act (FDCA) effected by the 21st Century Cures Act, which passed in 2016.
A 510(k) submission currently covers all medical devices that are “substantially equivalent” to devices currently on the U.S. market, or previous models of the same device. These applications are evaluated by the FDA’s Center for Devices and Radiological Health (CDRH) to ensure that any differences do not alter the new device’s safety or effectiveness profile.
The 21st Century Cures Act was a bipartisan bill signed into law by then-President Obama in December 2016, and aimed at increasing research funding for complex and challenging diseases, particularly mental health issues. The law also included substantial changes to the FDA’s regulatory process, aspects of which lawmakers determined were unnecessary and needlessly burdensome to industry stakeholders in ways that slowed innovation and patient access.
The agency stated in the Federal Register, alongside the list of now-exempt devices, that “FDA’s action will decrease regulatory burdens on medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.”
One of the amendments to the FDCA required the FDA to publish a list of medical devices that no longer required 510(k) premarket notifications. The list of class II devices published last month was required within 90 days, and a list of class I devices was expected within 120.
Medical devices are classified in one of three groups, depending on the amount of risk associated with their use. Class I medical devices are those products deemed to be low-risk, and as such are subject to the least amount of regulatory control. Devices on the class I exemption list include enzyme controls, tonometers, parallelometers, irrigating dental syringes, finger cots, and protective restraints for patients.
According to the agency, decisions to include or exclude devices of either class from the exemption list were based “on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.”
These exemptions do not come without limitations, and FDA stipulates that exemption from premarket notification does not provide exemption from other regulatory requirements. Additionally, the agency provided some exceptions to items included on the list.
The list of class II medical device exemptions is subject to 60 days of comment from regulators and industry stakeholders, but the class I list will go into effect immediately. In accordance with the amended FDCA, the agency is required to update the list every five years.