FDA-BENEFIT-RISK › Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics - Draft Guidance for Industry and Food and Drug Administration Staff

FDA-BENEFIT-RISK - 2018 EDITION - CURRENT
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Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics - Draft Guidance for Industry and Food and Drug Administration Staff


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Document Number

FDA-BENEFIT-RISK

Revision Level

2018 EDITION

Status

Current

Publication Date

Sept. 25, 2018

Page Count

25 pages