Exemptions for Unclassified Devices: CDRH Updates Guidance
Posted 08 February 2019 | By
The US Food and Drug Administration (FDA) on Friday updated a guidance from 2015 describing its intent to exempt certain unclassified medical devices from premarket notification requirements.
“Until the publication of a final rule exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period,” the guidance says.
Under the 21st Century Cures Act
, FDA was given the authority to exempt class I and II devices from premarket notification requirements on a periodic basis. To date, several of such devices
have been exempted
, and “for the purposes of this guidance, FDA has identified certain unclassified medical devices (that FDA intends to classify into class I or II) for which FDA believes premarket notification is not necessary to assure safety and effectiveness before these devices enter the marketplace.”
Unclassified devices FDA intends to exempt from premarket notification requirements include:
Ear, Nose, and Throat Devices
EWD – Protector, Hearing (Insert)
EWE – Protector, Hearing (Circumaural)
LEZ – Aids, Speech Training for the Hearing Impaired (AC-Powered and Patient Contact)
LFA – Aids, Speech Training for the Hearing Impaired (Battery-Operated or Non-Patient)
LRL – Cushion, Hemorrhoid
General and Plastic Surgical Devices
LKB – Pad, Alcohol, Device Disinfectant
LLN – Device, Vibration Threshold Measurement. This intention does not apply to devices that provide an interpretation or a clinical implication of the measurement.
LQW – Test, Temperature Discrimination. This intention does not apply to devices that provide an interpretation or a clinical implication of the measurement.
Obstetrical and Gynecological Devices
LHD – Device, Fertility Diagnostic, Proceptive
Physical Medicine Devices
LZW – Monitor, Spine Curvature