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Start Over Subjects Humans ✖Remove constraint Subjects: Humans Subjects Materials Testing -- standards ✖Remove constraint Subjects: Materials Testing -- standards

1. 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
Computer Security -- standards
Diagnostic Imaging
Models, Anatomic
Product Labeling -- standards
Reproducibility of Results
Software -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 20, 2019
Subject(s):
Device Approval -- standards
Materials Testing -- standards
Equipment and Supplies -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Metal expandable biliary stents: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration Staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 27, 2019
Subject(s):
Bile Ducts
Device Approval -- standards
Self Expandable Metallic Stents -- standards
Biocompatible Materials -- standards
Materials Testing -- standards
Product Labeling -- standards
Product Packaging -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.