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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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Electromagnetic compatibility (EMC) of medical devices: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, June 6, 2022

Subject(s):

Electromagnetic Fields
Equipment Design -- standards
Equipment Safety -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, November 28, 2017

Subject(s):

Equipment Safety -- standards
Product Labeling -- standards
Radiation Dosage
Radiation Exposure -- adverse effects
Radiation Exposure -- standards
Radiography -- adverse effects
Radiography -- instrumentation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Safety in the MR environment: MR safety screening practices

Publication:

[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2009

Subject(s):

Accident Prevention
Accidents
Equipment Safety -- standards
Magnetic Resonance Imaging -- adverse effects
Magnetics
Patient Care Planning
Patient Selection
United States

6. Safety in the MR environment: ferromagnetic projectile objects in the MRI scanner room

Publication:

[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2009

Subject(s):

Accident Prevention
Accidents
Equipment Safety -- standards
Magnetic Resonance Imaging -- adverse effects
Magnetics
United States