FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017

The Food and Drug Administration (FDA) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.

Read the final ruling here.