On July 11th, 2017 the FDA announced that they have determined that certain class II device will no longer meet the premarket notification requirements under section 510(k) of the Federal Food, Drug and Cosmetic Act. This published list of devices is in accordance to the 21st Century Cures Act and will decrease the regulatory burden on the medical device industry.
There are a number of factors that the FDA considers when determining whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factor are:
- The device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device.
- The characteristics of the device necessary for its safe and effective performance are well established.
- Changes in the device that could affect safety and effectiveness will either be readily detectable before causing harm or not increase the risk of injury, incorrect diagnosis or ineffective treatment.
- Any changes to the device will not be likely to result in a change to the device’s classification.
The FDA points out that an exemption from the 510(k) requirement does not mean that the device is exempt from any other statutory or regulatory requirement.
The FDA document announcing these exemptions can be found here. The majority of the document is comprised of three tables outlining the class II device exemptions. Table 1 lists the devices that no longer require premarket notification under section 510(k) of the FD&C Act. Table 2 lists the devices which contain partial exemptions and are subject to the general limitations to the exemptions found in the .9 section of Part 862 and 892 of Title 21 of the CFR. Table 3 list devices classified as Radioallergosorbent (RAST) immunological test systems that no longer requires a 510(k) premarket notification but is subject to Section .9 of Part 866 of Title 21 of the CFR.