Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Investigational Device Exemption (IDE), Premarket

Published

March 19, 1999

Last updated

March 18, 2020

Description

This document provides guidance for industry and FDA staff on preparing notices for investigational medical devices and recruiting study subjects.

Organization

Country / Region

United States

License

Other (Public Domain)

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