Subjects: Equipment Safety -- standards and United States. Department of Health and Human Services. - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Equipment Safety -- standards ✖ Subjects United States. Department of Health and Human Services. ✖ Publication Year 2000 to 2024 ✖

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. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017
Subject(s):: Equipment and Supplies -- standards
Equipment Design -- standards
Equipment Safety -- standards
Device Approval
Equipment Failure
Information Dissemination
Risk Management
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 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
Equipment Design -- standards
Equipment Safety -- standards
Product Labeling -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. 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.

5. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, October 30, 2017
Subject(s):: Product Labeling -- standards
Ultrasonic Surgical Procedures -- instrumentation
Ultrasonic Surgical Procedures -- standards
Equipment Safety -- standards
Leiomyoma -- surgery
Suction -- instrumentation
Suction -- standards
Surgical Equipment -- adverse effects
Ultrasonic Surgical Procedures -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff