Last December 30, the FDA issued the final version of the guidance “Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types“.
The purpose of this document is to define which kind of devices fall into the definition of Medical Device Accessories”, to classify them and to identify a specific risk-based regulatory procedure.
Moreover, the guidance explains how to use the De Novo registration procedure, intended for Class I and II innovative Medical Devices, in order to classify innovative accessories, in compliance with Section 513(f)(2) of the FD&C Act.
Furthermore, the guidance is applicable to all medical softwares classified as accessories, including those ones that meet the definition of “Software as a Medical Device (SaMD)”.
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