FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements
Posted 10 July 2017 | By
The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.
Established under the 21st Century Cures Act, the list, first published in draft form in March, is part of efforts to decrease regulatory burdens and costs for the device industry.
For the complete final list of devices exempted, see FDA’s Federal Register notice. FDA also previously identified more than 70 class I devices that are now exempt from 510(k) requirements.
FDA also noted that device types exempt from 510(k)s "are not exempt from other regulatory controls, unless such exemption is explicitly provided by order or regulation."
For instance, all devices must be manufactured under current good manufacturing practice requirements, be suitable for the intended use, be adequately packaged and properly labeled and have current establishment registration and device listing with FDA.
In addition, FDA says that sponsors with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should contact the 510(k) lead reviewer to discuss if the device falls within the general limitations of the exemption or exceeds the limitations (i.e., review of the 510(k) should continue).
"Sponsors with existing 510(k)s for device types that are now considered exempt are not required to take any action at this time," FDA said. "Sponsors who currently hold 510(k)s for device types that are partially exempt from premarket requirements must make a determination whether their specific devices are exempt or non-exempt."
Partial exemption limitations can be found in table 1 of the Federal Register Notice.
FDA also has assigned new product codes to the device types that are now exempt, subject to the partial limitations, to separate devices from those that do not fall within the partial exemption limitation under the existing product code.
"Sponsors should review their registration and listing information to assess if they should list their devices using the original classification product code, which requires premarket notification, or if they should use the new classification product code that is now 510(k) exempt," FDA said, adding: "If a sponsor chooses to list its device using a new procode, it should deactivate the existing listing and, create a new one, including the proprietary or brand names under which it is marketed…If a sponsor is marketing multiple devices that include products under both the original product code and the new product code, they should leave their existing listings under the old product code active, as appropriate, and create a new listing under the new product code."
In addition, device labelers that have submitted device identifiers DI records to the Global Unique Device Identification Database (GUDID) for devices types that are now exempt or partially exempt from premarket notification requirements should be aware that changes may need to be made to these records in the future, FDA said.