On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types. This guidance generally affirms the framework set forth in the Agency’s January 2015 draft version, which was intended to explain that accessories may be differently classified compared to their “parent” devices and to encourage use of the de novo process to obtain Class I or Class II classification for low-to-moderate risk accessories of a new type. The final guidance provides some additional examples, as well as nuanced clarifications, but the key messages are the same and remain in line with current FDA thinking. Of note, the final policy also represents FDA implementation of the accessories provision of the recently enacted 21st Century Cures Act.
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Source: Lexology – Hogan LovellsSuzanne LevyJonathan S. KahanJennifer Agraz Henderson and Yarmela Pavlovic