Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Drugs, Medical Devices

Topics

Over-the-Counter, Premarket

Published

September 29, 2020

Last updated

June 25, 2021

Description

This document provides guidance for the industry and FDA staff on over-the-counter self-monitoring blood glucose test systems.

Organization

Country / Region

United States

License

Other (Public Domain)

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