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1. Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, February 13, 2020

Subject(s):

Atherectomy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020

Subject(s):

Clinical Laboratory Techniques
Device Approval
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, March 3, 2020

Subject(s):

Device Approval
Suture Anchors
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020

Subject(s):

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

5. Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, March 27, 2020

Subject(s):

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

6. Medical devices

Author(s):

White, Robert S., author

Publication:

[Toronto, Ontario] : Thomson Reuters, 21-December-2020

Subject(s):

Device Approval
Equipment Safety
United States
United States. Food and Drug Administration

7. Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, May 2020

Subject(s):

Device Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, October 28, 2020

Subject(s):

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

9. Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020

Subject(s):

Blood Glucose Self-Monitoring
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020

Subject(s):

Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration