FDA exempts additional Class II devices from 510(k) requirements
The US Food and Drug Administration (FDA) on Tuesday finalized an order to exempt five types of Class II medical devices from 510(k) requirements, which the agency says will decrease regulatory burdens on industry for makers of those devices.Under the 21st Century Cures Act, FDA was instructed to publish lists of Class I and Class II devices it would exempt from 510(k) requirements at least once every five years. In 2017, FDA exempted more than 70 Class I devices and more than 1,000 Class II devices from 510(k) requirements in accordance with the act. (RELATED: FDA identifies more than 70 Class I devices now exempt from 510(k) requirements, Regulatory Focus 12 April 2017; FDA finalizes list of 1,003 Class II device types exempt from 510(k) requirements, Regulatory Focus 10 July 2017).
The latest order, first proposed in October, specifically lists exempt and non-exempt product codes for five types of devices and details limitations to the exemptions for four of the device types. (RELATED: FDA proposes additional Class II devices to be exempt from 510(k) requirements, Regulatory Focus 24 October 2019).
| 21 CFR Section | Device type | Exempt product code | Non-exempt product code |
| 884.6120 | Accessory, Assisted Reproduction | QKH | MQG |
| 884.6180 | Media, Reproductive | QKI | MQL |
| 888.4505 | Instruments Designed for Press-Fit Osteochondral implants | Not applicable | QBO |
| 890.5360 | Interactive Rehabilitation Exercise Devices | QKC | LXJ |
| 890.5670 | Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature | QKD | OSD |
For each device type other than instruments design for press-fit osteochondral implants, FDA has set limitations to the exemption. For instance, the exemption for interactive rehabilitation exercise devices is limited to prescription use only devices.
FDA also explains that it has “assigned new product codes to the device types that are exempt subject to the partial limitations to ensure that these devices can be separated from devices that do not fall within the partial exemption limitation under the existing product code.”