The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s.
FDA said in a statement that it “believes that the devices identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. The Agency periodically exempts from premarket notification review such medical devices when appropriate, the last time being in 2015.”
FDA must classify devices into one of three regulatory classes: Class I, or the class of lowest-risk devices, class II, which means some special controls are needed, or class III, which are for high risk devices that can be life-sustaining or life-supporting devices.
Section 3054 of the 21st Century Cures Act amended the Federal Food, Drug, & Cosmetic Act (FD&C Act), requiring FDA to publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness.
In explaining what the move will mean for industry, the agency says: “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. Specifically, regulated industry will no longer have to invest time and resources in 510(k) notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.”
In terms of the factors FDA considers to determine whether a 510(k) is necessary to provide reasonable assurance of safety and effectiveness for a class II device, FDA points to guidance from 1998, entitled "Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff."
FDA also says it will review any comments submitted within 60 days and will consider whether the list of class II devices should be modified prior to final publication.
FDA notes that an exemption from the requirement of premarket notification “does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation.”
The agency also notes that it may partially limit the exemption from premarket notification requirements to specific devices within a listed device type.
“In table 1, for example, FDA is listing the exemption of the endoscopic magnetic retriever, but limits the exemption to such devices that are for single use. All other endoscopic magnetic retrievers are still subject to premarket notification requirements because FDA determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.”
The hundreds of devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like umbilical clamps, obstetrical forceps and certain types of ophthalmoscopes. For the full list see the Federal Register notice below.
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments