Subjects: Medical Device Legislation and United States. Food and Drug Administration - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Medical Device Legislation ✖ Subjects United States. Food and Drug Administration ✖

1. Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2022
Subject(s):: Government Regulation
Medical Device Legislation
Terminology as Topic
United States
United States. Food and Drug Administration
United States.

2. Surveying, leveling, and alignment laser products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health , January 31, 2023
Subject(s):: Government Regulation
Lasers
Medical Device Legislation
Weights and Measures
United States
United States. Food and Drug Administration

3. Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act during the COVID-19 public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2020
Subject(s):: Equipment and Supplies
Manufacturing Industry
Medical Device Legislation
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Regulatory considerations for microneedling products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 10, 2020
Subject(s):: Medical Device Legislation
Needles -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Requesting FDA feedback on combination products: guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020
Subject(s):: Biological Products
Formative Feedback
Legislation, Drug
Medical Device Legislation
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):: Medical Device Legislation
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. Transition plan for medical devices that fall within enforcement policies issued during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry, other stakeholders, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Subject(s):: Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration

9. Transition plan for medical devices issued emergency use authorizations (EUAs) related to coronavirus disease 2019 (COVID-19): guidance for industry, other stakeholders, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Subject(s):: Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration

10. Enforcement policy for face masks and barrier face coverings during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):: COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
Personal Protective Equipment
United States
United States. Food and Drug Administration