Subjects: Product Labeling / Copyright: Public domain - Digital Collections - National Library of Medicine Search Results

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11. Testing and labeling medical devices for safety in the magnetic resonance (MR) environment: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):: Device Approval
Equipment Safety
Magnetic Resonance Imaging -- instrumentation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

12. Enforcement policy regarding use of national health related item code and national drug code numbers on device labels and packages: guidance for industry and Food and Drug Administration Staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 21, 2021
Subject(s):: Government Regulation
Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

13. Surgical staplers and staples for internal use: labeling recommendations : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 8, 2021
Subject(s):: Product Labeling
Surgical Staplers
Sutures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

14. Submission of plans for cigarette packages and cigarette advertisements (revised)

Publication:: Silver Spring, MD : Center for Tobacco Products, July 2021
Subject(s):: Advertising
Government Regulation
Product Labeling
Tobacco Products
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

15. Unique Device Identification System: form and content of the unique device identifier (UDI) : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, July 7, 2021
Subject(s):: Equipment and Supplies
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

16. Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):: Equipment Safety
Lasers -- classification
Lasers -- standards
Certification
Device Approval -- standards
Guideline Adherence
Product Labeling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization

Publication:: Silver Spring, MD : Center for Tobacco Products, January 2020
Subject(s):: Commerce -- legislation & jurisprudence
Electronic Nicotine Delivery Systems -- standards
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- standards
Adolescent
Government Regulation
Product Labeling
Vaping -- prevention & control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, July 27, 2023
Subject(s):: Contact Lens Solutions
Device Approval
Government Regulation
Hydrogen Peroxide
Product Labeling
United States
United States. Food and Drug Administration

19. Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023
Subject(s):: Government Regulation
Medical Device Legislation
Microbial Sensitivity Tests -- standards
Product Labeling
United States

20. Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Subject(s):: Biological Products -- administration & dosage
Drug Dosage Calculations
Drug Industry
Drug Labeling
Drug Packaging
Government Regulation
Injections -- standards
Prescription Drugs -- administration & dosage
Product Labeling
Product Packaging
United States