FDA Drafts List of Class II Devices Exempt From 510(k) Notifications
In accordance with the recently passed 21st Century Cures Act, the FDA is compiling a list of class II medical devices that will no longer be subject to premarket notification requirements, or 510(k)s. A draft of the list will be available for comment for 60 days and, once finalized, the exemptions are expected to reduce financial burden on the medical device industry.
Currently, all medical devices intended for human use but not required to apply for premarket approval (PMA) must submit a 510(k) to the FDA, as directed by the Federal Food, Drug and Cosmetic Act (FDCA). A 510(k) is covers premarket submissions that are “substantially equivalent” to one or more devices currently on the market, and is required prior to the device’s introduction to the U.S. market, or whenever a substantial change has been made to the device that could alter its safety profile.
In December, then-President Barack Obama signed the 21st Century Cures Act into law, implementing several significant changes to pharmaceutical and device regulation in the U.S., and launching several ambitious research initiatives. One part of the law focuses on reducing red-tape in both research and regulatory processes, and has amended certain FDCA filing requirements. One of these amendments stipulates that the FDA will publish a list of class II devices that are exempt from 510(k) notifications within 90 days of passage of the law.
FDA believes that items included on the draft list are “sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness,” according to the Regulatory Affairs Professionals Society (RAPS).
In the FDA’s introduction to its current list, published on the Federal Register, the agency explains that its criteria for exemption was established in a guidance published in 1998, Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff. The agency also stipulates that 510(k) exemption does not necessarily provide exemption from other regulatory or statutory requirements.
The draft list is expected to expand as the industry and regulatory stakeholders weigh in, but currently includes devices such as continuous glucose monitor (CGM) secondary displays, certain pieces of lab equipment, immunoassays, and other diagnostic tests, as well as surgical drapes, lamps, and certain instruments. Exemptions for wires, guides, and catheters are limited to those devices that are manually operated and do not come into direct contact with patients. Other device exemptions, such as endoscopic magnetic retrievers, apply only to devices that are single-use.
“FDA’s final action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation,” wrote the agency.
Related, Scott Gottlieb, physician and former FDA official, is expected to receive the nomination for FDA commissioner in the coming months. Gottlieb is a long-time proponent of “deregulation and free-market health policy” and is expected to champion even more red tape cutting over the next few years. Critics are concerned that he will “open the floodgates” to potentially dangerous drugs and devices.