Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff

Name: Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: guidances,industry,performance,pre-market,submissions,testing

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

December 20, 2019

Last updated

October 20, 2020

Description

Guidance document outlining the recommended content and format for non-clinical bench performance testing in premarket submissions.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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