NLM Digital Collections

Search

Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects Product Labeling ✖Remove constraint Subjects: Product Labeling

11. Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):
Breast Implants
Equipment Safety
Product Labeling
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. 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):
Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

14. 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

15. 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

19. 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.

20. 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.