NLM Digital Collections

Search

Start Over Formats Text ✖Remove constraint Formats: Text Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Subjects Device Approval -- standards ✖Remove constraint Subjects: Device Approval -- standards Genre Guideline ✖Remove constraint Genre: Guideline

1. 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.

2. 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.

3. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : 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
Clinical Protocols
Research Design
Telecommunications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2017
Subject(s):
Equipment and Supplies -- standards
Equipment Reuse -- standards
Product Labeling -- standards
Device Approval -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.