FDA Finalizes 510(k) Exemptions for Certain Class II Devices

On June 5^th, 2018, the Federal Register for the FDA was updated to include exemptions for some class II medical devices. This update was a result of the Century Cures Act of 2016, which allows the FDA to under its own prerogative or through the petition of an interested person, exempt a class II device from being required to submit a 510(k) report. The factors that are used to determine the exemptions are as follows: the device does not have a significant history of false or misleading claims or risks, the characteristics of the device necessary for safe use are well established, changes that would reduce the safety of the device are easily detectable or would not increase the risk of the device and any changes to the device would not likely change the class of the device.

The types of devices that are now exempt are:

• Total 25-hydroxyvitamin D Mass Spectrometry Test System (PSL)
• Genetic Health Risk Assessment System (PTA)
• Endoscope Disinfectant Basin (PUP)
• Medical Ultraviolet Water Purifier (KXG)
• Vibrator for Therapeutic Use, Genital (KXQ)

A premarket notification is still required for genetic health risk assessment systems as they must provide assurance that the device is safe and works properly. This was put into place to mitigate the risk of false negative and positives that may result in the injury or death of those being tested.

For more information please visit Federal Register / Vol. 83, No. 108

These exemptions provide a way for the FDA to reduce the waiting time for 510(k) submissions to be reviewed as there will be a reduction in the total number of them being submitted. However, these exemptions may not be beneficial if medical device manufacturers do not continue to ensure that their products are of the utmost quality.

? For any questions or comments or your regulatory requirement please email to [email protected] or use our contact form.