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The FDA issued a draft guidance on January 16, 2015, titled "Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types". The primary goal of this draft guidance was to describe the use of the de novo classification process to classify accessories of a new type under Section 513(f)(2) of the FD&C Act. The FDA encourages manufacturers and other parties to utilize the de novo classification process in Section 513(f)(2) of the FD&C Act to request risk-based classifications of new types of accessories. This guidance states that the FDA must make a classification determination for the device that is the subject of the de novo by written order within 120 days of the request (see Section 513(f)(2)(A)(iii) of the FD&C Act). The de novo process provides a pathway to Class I or Class II classification for accessories for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there are no legally marketed predicate device. Recommendations were contained in this guidance to try and streamline the submission and evaluation of the accessory de novo so that only information necessary to assess accessory safety and effectiveness is submitted and reviewed.
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