Last month FDA published a guidance (titled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”) announcing that they would not be enforcing compliance with 510(k) requirements for certain classes of medical devices, and with that announcement they released a list of the 120 exempt classes (full list of exempt device classes here). This meant any devices falling into one of the 120 exempt classes would no longer have to comply with FDA’s premarket notification and review requirements, making it significantly easier to get device(s) on the market faster.
Last week, FDA updated this guidance adding eight additional classes that will no longer be required to comply with the Agency’s premarket notification and review requirements. The additional classes include the following:
Cardiovascular Devices:
- DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Gastroenterology Devices:
- OCY – Endoscopic Guidewire, Gastroenterology-urology
- KOE – Dilator, Urethral
General & Plastic Surgical Devices:
- FTA – Light, Surgical, Accessories
Neurological Devices:
- GZM – Analyzer, Rigidity
- GZO – Device, Galavanic Skin Response Measurement
- HCJ – Device, Skin Potential Measurement
Ophthalmic Devices:
- HLJ – Ophthalmoscope, Battery Powered
Not sure if your device falls into one of the exempt categories or not? We can help figure it out and achieve a successful outcome with FDA during the entire process of getting your medical device on the market. For more information on our services and how we can help you, please contact us.
