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4. Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):
Device Approval
Equipment Safety
Morcellation -- adverse effects
Morcellation -- instrumentation
Product Labeling
Leiomyoma -- surgery
Uterine Neoplasms -- surgery
Humans
United States
United States. Food and Drug Administration

9. Unique device identification: Policy regarding compliance dates for class I and unclassified devices, direct marking, and Global Unique Device Identification Database requirements for certain devices : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 25, 2022
Subject(s):
Databases as Topic
Equipment and Supplies
Government Regulation
Product Labeling
United States
United States. Food and Drug Administration

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

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 1, 2020
Subject(s):
Equipment and Supplies -- standards
Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. 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.

14. 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

15. 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

16. 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

20. 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.

21. 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.

22. 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

24. 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