Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA Staff

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Administrative / Procedural, Digital Health, Premarket

Published

December 20, 2017

Last updated

October 3, 2022

Description

This document is a guidance for the medical device industry and FDA staff on describing and classifying medical device accessories.

Organization

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

Actions

Social networks

Embed