To streamline the medical device approval process and bring treatments to patients who need them faster and more efficiently, the US FDA was given the authority to exempt class I and II devices from premarket notification requirements on a periodic basis under the 21st Century Cures Act.
Committed to their goal, the FDA identified certain low-risk Medical Devices for which the premarket notification was deemed not necessary to ensure their safety and effectiveness before their placement on the market and, on February 8, 2019, released an updated guidance “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements”.
Consequently, the FDA intends to classify as class I and II the following (unclassified) Medical Devices, listed under Section IV of the guidance:
- Ear, Nose, and Throat Devices (product codes: EWD, EWE, LEZ and LFA);
- Gastroenterology-Urology Devices (product code: LRL);
- General and Plastic Surgical Devices (product code: LKB);
- Neurological Devices (product codes: LLN and LQW. Note: the intention does not apply to devices that provide an interpretation or a clinical implication of the measurement);
- Obstetrical and Gynecological Devices (product code: LHD); and
- Physical Medicine Devices (product code: LZW)
and, ultimately, propose their exemption from premarket notification requirements.
If adopted, the guidance will supersede “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements” issued August 14, 2015.