Draft FDA Guidance for Industry

Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types

This guidance document is being distributed for comment purposes only. 

Document issued on: January 20, 2015.

The Food and Drug Administration (FDA) developed this draft document to provide guidance to industry and FDA staff about the regulation of accessories to other medical devices.

This guidance is intended to clarify and modify FDA’s policy concerning the classification of accessories and to discuss the application of that policy to specific categories of devices that are commonly used as accessories to other medical devices. 

In addition, this guidance also encourages utilization of the de novo classification process under Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to allow manufacturers and other parties to request risk-based classification of accessories of a new type (i.e., accessories of a type that has not been previously classified under the FD&C Act or approved in an application for premarket approval (PMA)).

Download FDA Guidance in PDF Below

Download “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types” ucm429672.pdf – Downloaded 299 times – 309 KB

FDA Guidance for Defining Accessories and Classification Pathway for New Accessory Types
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