NLM Digital Collections

Search

Start Over Subjects Equipment and Supplies -- classification ✖Remove constraint Subjects: Equipment and Supplies -- classification Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services. Genre Guideline ✖Remove constraint Genre: Guideline

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.