General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Digital Health, Premarket

Published

September 27, 2019

Last updated

September 26, 2019

Description

This document is a guidance for the industry and FDA staff on the policy for low-risk devices in the field of general wellness.

Organization

Country / Region

United States

License

Other (Public Domain)

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