Subjects: Device Approval and Government Regulation / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Device Approval ✖ Subjects Government Regulation ✖ Genre Guideline ✖

1. Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 22, 2022
Subject(s):: Device Approval
Government Regulation
United States
United States. Food and Drug Administration

2. Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022
Subject(s):: Diagnosis, Computer-Assisted
Device Approval
Government Regulation
Radiographic Image Interpretation, Computer-Assisted
United States
United States. Food and Drug Administration

3. Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Clinical Studies as Topic
Device Approval
Government Regulation
United States
United States. Food and Drug Administration

4. Peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, April 14, 2023
Subject(s):: Angioplasty, Balloon, Coronary
Cardiac Catheters
Device Approval
Government Regulation
United States

5. Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
Subject(s):: Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.

6. Soft (hydrophilic) daily wear contact lenses: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Subject(s):: Contact Lenses, Hydrophilic -- standards
Device Approval
Equipment Safety
Government Regulation
United States

7. General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Subject(s):: Animal Experimentation
Animal Welfare
Animals, Laboratory
Device Approval
Equipment Safety
Equipment and Supplies
Government Regulation
United States

8. Content of premarket submissions for device software functions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2023
Subject(s):: Device Approval
Government Regulation
Software -- legislation & jurisprudence
Software -- standards
Software Design
United States

9. Non-clinical performance assessment of tissue containment systems used during power morcellation procedures: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 26, 2023
Subject(s):: Device Approval
Government Regulation
Morcellation -- instrumentation
Morcellation -- legislation & jurisprudence
Morcellation -- standards
United States

10. Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, July 27, 2023
Subject(s):: Contact Lens Solutions
Device Approval
Government Regulation
Hydrogen Peroxide
Product Labeling
United States
United States. Food and Drug Administration