Subjects: Product Labeling and United States. Food and Drug Administration - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Product Labeling ✖ Subjects United States. Food and Drug Administration ✖

1. 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

2. 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

3. Instructions for use: patient labeling for human prescription drug and biological products : content and format

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Government Regulation
Prescription Drugs
Product Labeling
United States
United States. Food and Drug Administration

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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