Regulations.gov document

Reference 7 - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions…

Supporting & Related Material · FDA-2017-D-6535 · posted Mar 26, 2019

Key facts

Document ID FDA-2017-D-6535-0016
Title Reference 7 - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-2017-D-6535
Posted Mar 26, 2019

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