Subjects: Device Approval -- standards - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Device Approval -- standards ✖

1. 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.

2. 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.

3. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):: Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):: Device Approval -- standards
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

5. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):: Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 30, 2017
Subject(s):: Classification
Device Approval -- standards
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. 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.

8. 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.

9. Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2017
Subject(s):: Device Approval -- standards
Communication
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):: Data Display -- standards
Image Processing, Computer-Assisted -- standards
Radiology Information Systems -- standards
Device Approval -- standards
Product Labeling -- standards
Software -- standards
Technology, Radiologic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.