Subjects: Device Approval / Languages: English / Recently Added: Within 6 Months - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Device Approval ✖ Languages English ✖ Recently Added Within 6 Months ✖

1. FDA repeatedly adapted emergency use authorization policies to address the need for COVID-19 testing

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
Subject(s):: COVID-19 Testing
Device Approval
Government Regulation
United States
United States. Food and Drug Administration

2. 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

3. Breakthrough Devices 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):: Data Collection
Device Approval
Government Regulation
Medical Device Legislation
United States
United States.
United States.

4. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 8, 2023
Subject(s):: Biological evaluation of medical devices
Device Approval
Equipment and Supplies -- adverse effects
Government Regulation
Guidelines as Topic
United States

5. Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 2023
Subject(s):: Bioengineering
Device Approval
Drug Development
Drug Industry
Ergonomics
Government Regulation
United States

6. Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 3, 2023
Subject(s):: Device Approval
Government Regulation
Guideline Adherence
Thermometers -- standards
United States

7. Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2, 2023
Subject(s):: Compassionate Use Trials
Device Approval
Government Regulation
Guideline Adherence
United States

8. Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Correspondence as Topic
Device Approval
Government Regulation
Manufacturing Industry
United States
United States.

9. Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Computer Simulation
Device Approval
Government Regulation
United States