Exhaustive Extractions

At iuvo, we work hard to stay on the cutting edge of new developments in testing and regulatory changes affecting the medical device and pharmaceutical industries. We will share these updates regularly here in our blog - Exhaustive Extractions.

FDA Releases 71 Device Product Codes Exempt from All Premarket Notification Requirements

 

On April 13, 2017, as part of the US FDA’s continued efforts to comply with the 21st Century Cures Act of 2016, the Agency published a list of 71 low-risk Class I medical device product codes that are exempt from all premarket notification requirements (i.e. 510(k) clearance). While the list includes product codes for ophthalmic and neurological devices, the majority of the devices are for clinical chemistry and clinical toxicology analyte controls.  

For more information on the FDA’s notification, including the full list of exempted product codes, refer to the attached link

 

 

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