New Class II 510(k) Exempt Medical Devices
As part of the FDA’s movement to decrease regulatory burdens on the medical device industry, the agency published a list of more than 337 Class II product codes of 510(k) exempt medical devices (see the FDA’s Federal Register notice). The FDA has determined that assurance of safety and effectiveness of these devices can be provided by other regulatory controls. By issuing exempt status for these devices, the FDA can redirect resources that would have been spent reviewing these submissions to more significant public health issues.
In March of this year, the FDA published a draft of their proposed Class II devices to be exempted in accordance with the 21st Century Cures Act. FDA is now required to publish a list of Class II devices that no longer require premarket notification, also known as 510(k) exempt medical devices, at least once every five years. 93 product codes are now 510(k) exempt subject to partial exemption limitation in addition to general limitations. So, it will be important for manufacturers to confirm if their device is indeed exempt. For example, FDA exempted devices regulated under product code DHB (Radioallergosorbent immunological test system), but they do not believe all products with the product code DHB meet the partial exemption limitation. Therefore, you are still required to file a 510(k) submission if your device falls under product code DHB and is not identified on the list.
Pending 510(k) Submissions
Medical device manufacturers with pending 510(k) submissions that are now on the list of exempted devices are directed to withdraw their submission. This is great news for these companies because they will be able to immediately go to market if they have met the applicable general and partial limitations and all other applicable quality and regulatory requirements. Although certain Class II devices may not be required to go through the process of FDA 510(k) premarket notification, they are not exempt from other controls. These devices will still be required to have:
- Implemented a Quality Management System
- Met the applicable requirements of 21 CFR Part 820
- Met necessary labeling requirements
- Completed FDA registration and listing
Manufacturers with devices subject to exemption limitations should contact their lead reviewer to determine if their product exceeds the limitations and should continue the 510(k) process. Limitations will vary depending on the product affected. For example, some immunoassays are only 510(k) exempt if their test systems are intended solely for employment and insurance testing. These products will not be exempted if they are intended for other use. FDA has created new product codes for 510(k) exempt medical devices that are subject to partial limitations in order to distinguish them from those that do not fall within the partial limitations.
Reassessing Your Product Code
Manufacturers are encouraged to review their registration and listing information to determine if they should use the new product code that is 510(k) exempt or if their device should be listed using the original product code. Additionally, if device identifier (DI) records have been submitted to the Global Unique Device Identification Database (GUDID) for devices that are now exempt or partially exempt, then manufacturers should be aware that changes may have to be made to these records, as well.