Updated FDA Guidance regarding Medical Device Accessories and Classification Pathways!!

The FDA has just released an updated final guidance entitled, “Medical Device Accessories – Describing Accessories and Classification Pathways”.  This guidance was originally issued out to industry and FDA staff one year ago in December of 2016.  This update focuses on explaining new mechanisms to request either a different classification for an existing accessory type or for new accessory types.

The main focus of this guidance is to help with the classification of medical device accessories.  The guidance begins by helping define what an accessory is and then leads into a determination of whether the accessory should be included under the same classification as the parent device or included under a different classification.  The guidance then guides the reader through the process of requesting classification for an accessory from the FDA.

 

? For any questions or comments or your regulatory requirement please email to info@mdiconsultants.com or use our contact form. Ref: Medical Device Accessory Classification.