Subjects: Medical Device Legislation / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Medical Device Legislation ✖ Genre Guideline ✖

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. 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

4. 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

5. 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

6. Enforcement policy for face shields, surgical masks, and respirators 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
N95 Respirators -- standards
Personal Protective Equipment
Respiratory Protective Devices -- standards
United States
United States. Food and Drug Administration

7. Technical considerations for medical devices with physiologic closed-loop control technology: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2023
Subject(s):: Equipment Design
Equipment Safety
Government Regulation
Medical Device Legislation
Monitoring, Physiologic
United States

8. Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023
Subject(s):: Government Regulation
Medical Device Legislation
Microbial Sensitivity Tests -- standards
Product Labeling
United States

9. Cybersecurity in medical devices: quality system considerations and content of premarket submissions : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2023
Subject(s):: Computer Security
Device Approval
Equipment Safety
Government Regulation
Medical Device Legislation
United States

10. Fostering medical device improvement: FDA activities and engagement with the voluntary improvement program : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 15, 2023
Subject(s):: Government Regulation
Medical Device Legislation
Quality Improvement
Voluntary Programs
United States