Subjects: Software -- standards and United States - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Software -- standards ✖ Subjects United States ✖ Publication Year 2017 ✖

1. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):: Data Display -- standards
Image Processing, Computer-Assisted -- standards
Radiology Information Systems -- standards
Device Approval -- standards
Product Labeling -- standards
Software -- standards
Technology, Radiologic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017
Subject(s):: Device Approval -- standards
Software -- standards
Computer Security
Equipment Design -- standards
Equipment Safety -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. 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.

4. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 8, 2017
Subject(s):: Equipment and Supplies -- standards
Reproducibility of Results
Software -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.