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1. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):
Registries -- standards
Tobacco Products -- standards
Manufacturing and Industrial Facilities -- standards
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

2. Medical product communications that are consistent with the FDA-required labeling: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Communication
Drug Labeling -- standards
Product Labeling -- standards
Equipment and Supplies -- standards
Pharmaceutical Preparations -- 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. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, October 30, 2017
Subject(s):
Product Labeling -- standards
Ultrasonic Surgical Procedures -- instrumentation
Ultrasonic Surgical Procedures -- standards
Equipment Safety -- standards
Leiomyoma -- surgery
Suction -- instrumentation
Suction -- standards
Surgical Equipment -- adverse effects
Ultrasonic Surgical Procedures -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. 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.

9. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 28, 2017
Subject(s):
Equipment Safety -- standards
Product Labeling -- standards
Radiation Dosage
Radiation Exposure -- adverse effects
Radiation Exposure -- standards
Radiography -- adverse effects
Radiography -- instrumentation
Adolescent
Child
Child, Preschool
Contraindications
Fluoroscopy -- adverse effects
Fluoroscopy -- instrumentation
Infant
Infant, Newborn
Radiation, Ionizing
Tomography Scanners, X-Ray Computed -- standards
Tomography, X-Ray Computed -- adverse effects
Young Adult
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, December 5, 2017
Subject(s):
Computer-Aided Design -- standards
Device Approval
Manufactured Materials -- standards
Materials Testing -- standards
Printing, Three-Dimensional -- standards
Quality Control
Computer Security -- standards
Diagnostic Imaging
Models, Anatomic
Product Labeling -- standards
Reproducibility of Results
Software -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. 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.

13. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Electronic Nicotine Delivery Systems -- standards
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Product Labeling -- standards
Vaping -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

14. Pediatric information incorporated into human prescription drug and biological product labeling

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Labeling -- standards
Pediatrics
Product Labeling -- standards
Adolescent
Biological Products
Child
Child, Preschool
Infant
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. Unique device identification: convenience kits : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, April 26, 2019
Subject(s):
Equipment and Supplies -- standards
Product Labeling -- standards
Equipment Reuse
Product Packaging -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Product Labeling -- legislation & jurisprudence
Vaping -- legislation & jurisprudence
Commerce -- legislation & jurisprudence
Guideline Adherence
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

17. 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.

18. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, September 2019
Subject(s):
Bacteriological Techniques
Blood Banks -- standards
Blood Platelets -- microbiology
Blood Preservation -- standards
Platelet Transfusion -- standards
Transfusion Reaction -- prevention & control
Product Labeling -- standards
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Food labeling: serving sizes of foods that can reasonably be consumed at one eating occasion, reference amounts customarily consumed, serving size-related issues, dual-column labeling, and miscellaneous topics

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Food Safety and Applied Nutrition, December 2019
Subject(s):
Diet, Healthy
Food Labeling -- standards
Portion Size -- standards
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.