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

Start Over Subjects Device Approval -- standards ✖ Subjects United States. Department of Health and Human Services. ✖

11. Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 16, 2019
Subject(s):: Device Approval -- standards
Checklist
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Refuse to accept policy for 510(k)s: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, September 13, 2019
Subject(s):: Device Approval -- standards
Checklist
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 15, 2019
Subject(s):: Biological Products -- standards
Device Approval -- standards
Equipment and Supplies -- standards
Disease Transmission, Infectious -- prevention & control
Encephalopathy, Bovine Spongiform -- transmission
Sterilization -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 20, 2019
Subject(s):: Device Approval -- standards
Materials Testing -- standards
Equipment and Supplies -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 16, 2019
Subject(s):: Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

16. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 7, 2019
Subject(s):: Congresses as Topic -- standards
Device Approval -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Utilizing animal studies to evaluate organ preservation devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):: Device Approval -- standards
Evaluation Studies as Topic
Organ Preservation -- instrumentation
Organ Preservation -- standards
Perfusion -- instrumentation
Reperfusion -- instrumentation
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Medical x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):: Device Approval -- standards
Electrical Equipment and Supplies -- classification
Electrical Equipment and Supplies -- standards
Radiography -- classification
Radiography -- instrumentation
Equipment Safety
Guideline Adherence
Tomography Scanners, X-Ray Computed -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):: Equipment Safety
Lasers -- classification
Lasers -- standards
Certification
Device Approval -- standards
Guideline Adherence
Product Labeling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Metal expandable biliary stents: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration Staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 27, 2019
Subject(s):: Bile Ducts
Device Approval -- standards
Self Expandable Metallic Stents -- standards
Biocompatible Materials -- standards
Materials Testing -- standards
Product Labeling -- standards
Product Packaging -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.