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1. FDA should further integrate its review of cybersecurity into the premarket review process for medical devices

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2018
Subject(s):
Computer Security
Device Approval -- standards
Equipment and Supplies -- standards
Equipment Safety -- standards
Computer Communication Networks -- standards
Guidelines as Topic
Software -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. 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.

3. 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.

4. 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.

5. 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.