FDA to exempt five more unclassified devices from premarket notification
The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices from premarket notification requirements.
The announcement was made via an update to the agency’s guidance, Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements, which was originally issued in 2015 and was updated to include additional devices in a prior update in 2019. (RELATED: Exemptions for Unclassified Devices: CDRH Updates Guidance, Regulatory Focus 8 February 2019)
According to FDA, five additional product codes have been reviewed by panels and recommended for classification as class I or class II. The updated guidance now features a total of 13 product codes.
Most class I and some class II devices are exempt from the FDA's premarket notification (510(k)) requirements.
In the proposal, issued in a draft guidance, FDA announced that “at this time, and based on the information currently available to the Agency, FDA believes the devices identified in this guidance meet the standards for exemption from premarket notification.”
FDA said the guidance has been implemented without prior comment, but it remains open for comments in accordance with the Agency's good guidance practices.
Issuance of the guidance fulfills one of the goals in the commitment letter that was drafted as part of the reauthorization process for the Medical Device User Fee Amendments of 2012. In this letter, FDA committed to proposing exemptions for certain low-risk medical devices to exempt from premarket notification requirements.
Unclassified devices FDA intends to exempt from premarket notification requirements include:
- Physical Medicine Devices: LDK – Device, Sensing, Optical Contour
- Neurological Devices: MVV – Device, Acupressure
- General and Plastic Surgical Devices: MQZ – Prosthesis, Nail
- Toxicology Devices: MIG – Strip, Test Isoniazid
- Ophthalmic Devices: LXQ – Cup, Eye
