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Start Over Subjects Equipment and Supplies -- classification ✖Remove constraint Subjects: Equipment and Supplies -- classification

1. How to prepare a pre-request for designation (pre-RFD)

Publication:
[Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018
Subject(s):
Equipment and Supplies -- classification
Drugs, Investigational -- classification
Investigational New Drug Application
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 1, 2017
Subject(s):
Advisory Committees -- organization & administration
Device Approval
Equipment and Supplies -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

Publication:
Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017
Subject(s):
Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. 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.

5. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, January 16, 2018
Subject(s):
Equipment and Supplies -- classification
Product Labeling -- standards
Product Packaging -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Gastroenterology -- instrumentation
Gynecology
Obstetrics -- instrumentation
Otolaryngology -- instrumentation
Physical and Rehabilitation Medicine -- instrumentation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Evaluation of devices used with regenerative medicine advanced therapies

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):
Cost-Benefit Analysis
Device Approval
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. 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.