The U.S. Food and Drug Administration (FDA) has issued a final guidance on the appropriate description and classification of accessory products used in conjunction with medical devices.
Under law, most accessories used in conjunction with medical devices are subject to FDA regulations, and have either been included in the same classification as the parent device, or have been assigned to a separate classification in cases where the accessory presents a different risk profile from that of the parent device. The new guidance describes in detail what the FDA considers to be an “accessory,” and how the FDA evaluates the applicable risk associated with that accessory in determining the appropriate device classification.
Originally published as a draft guidance in late 2016, the final guidance was issued on December 20, 2017. Like all guidance documents issued by the FDA and other U.S. federal agencies, the final guidance is intended solely to provide insight into the agency’s current thinking on a topic and does not establish legally-enforceable responsibilities.
