Subjects: Equipment Safety / Recently Added: Within 6 Months - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Equipment Safety ✖ Recently Added Within 6 Months ✖

1. 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

2. Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
Subject(s):: Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.

3. Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Data Collection
Digital Health
Equipment Design
Equipment Safety
Government Regulation
Medical Device Legislation
Remote Sensing Technology -- standards
United States

4. Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 19, 2023
Subject(s):: Equipment Safety
Government Regulation
Guideline Adherence
Monitoring, Physiologic
Remote Sensing Technology
United States

5. General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Subject(s):: Animal Experimentation
Animal Welfare
Animals, Laboratory
Device Approval
Equipment Safety
Equipment and Supplies
Government Regulation
United States

6. Medical devices

Author(s):: White, Robert S., (Compliance Attorney and member of the Oklahoma Bar), author
Publication:: [Toronto, Ontario] : Thomson Reuters, 19-December-2022
Subject(s):: Device Approval
Product Surveillance, Postmarketing
Equipment Safety
Medical Device Recalls -- legislation & jurisprudence
United States
United States. Food and Drug Administration

7. Soft (hydrophilic) daily wear contact lenses: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Subject(s):: Contact Lenses, Hydrophilic -- standards
Device Approval
Equipment Safety
Government Regulation
United States

8. 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