Collections: Health Policy and Services Research / Subjects: Product Labeling - Digital Collections - National Library of Medicine Search Results

Start Over Collections Health Policy and Services Research ✖ Subjects Product Labeling ✖ Publication Year 2020 to 2021 ✖

1. 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.

2. 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.

3. Product labeling for laparoscopic power morcellators: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 30, 2020
Subject(s):: Laparoscopy
Morcellation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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.