Subjects: Manufactured Materials -- standards - Digital Collections - National Library of Medicine Search Results

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NLM Digital Collections

Start Over Subjects Manufactured Materials -- standards

1. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 16, 2019
Subject(s):: Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

2. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 5, 2017
Subject(s):: Computer-Aided Design -- standards
Device Approval
Manufactured Materials -- standards
Materials Testing -- standards
Printing, Three-Dimensional -- standards
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration