FDA to exempt handful of devices from 510(k) requirements
- FDA announced Friday in a new guidance it will not require 510(k)s for a handful of medical devices, such as certain hearing aids and pregnancy diagnostics, and will exercise enforcement discretion for the 510(k) requirements until a final rule is published.
- FDA committed to identifying low-risk devices for exemption from 510(k) requirements as part of the commitment letter for the Medical Device User Fee Amendments of 2012. The new action updates the list of devices it exempted in guidance issued on Aug. 14, 2015, to exclude product codes that have been exempted through other actions related to the 21st Century Cures Act, the agency said.
- The regulatory agency is using its authority gained under Cures to exempt certain unclassified devices — intended to be sorted into Class I or Class II — that are well understood and "no longer warrant 510(k) review prior to allowing the manufacturer to market the device."
The latest deregulatory step by FDA does not exempt the devices from other regulatory requirements such as registration and listing, labeling, good manufacturing practices and medical device reporting requirements.
FDA also notes that combination products and single-entity products with an antimicrobial agent are not intended to be exempted by the guidance.
Device types FDA still intends to exempt from 510(k) requirements include the following product codes:
- EWD – Protector, Hearing (Insert)
- EWE – Protector, Hearing (Circumaural)
- LEZ – Aids, Speech Training for the Hearing Impaired (AC-Powered and PatientContact)
- LFA – Aids, Speech Training for the Hearing Impaired (Battery-Operated or NonPatient)
- LRL – Cushion, Hemorrhoid
- LKB – Pad, Alcohol, Device Disinfectant
- LLN – Device, Vibration Threshold Measurement.
- LQW – Test, Temperature Discrimination.
- LHD – Device, Fertility Diagnostic, Proceptive
- LZW – Monitor, Spine Curvature
- FDA Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements
- FDA MDUFA Commitment Letter
- Congress.gov 21st Century Cures Act
- Regulations.gov 2015 Final Guidance: Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements Guidance for Industry and Food and Drug Administration Staff
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