Collections: Health Policy and Services Research / Subjects: Government Regulation - Digital Collections - National Library of Medicine Search Results

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551. Certain Medicare beneficiaries, such as urban and Hispanic beneficiaries, were more likely than others to use telehealth during the first year of the COVID-19 pandemic

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
Subject(s):: COVID-19
Government Regulation
Hispanic or Latino
Medicare
Telemedicine -- statistics & numerical data
Urban Population
United States

552. Home health agencies used multiple strategies to respond to the COVID-19 pandemic, although some challenges persist

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, October 2022
Subject(s):: COVID-19
Government Regulation
Home Care Agencies -- organization & administration
Home Care Agencies -- statistics & numerical data
United States

553. For Medicaid-enrolled children diagnosed with lead toxicity in five states, documentation reviewed for diagnoses and treatment services raises concerns

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, December 2022
Subject(s):: Child
Data Accuracy
Government Regulation
Lead Poisoning -- diagnosis
Lead Poisoning -- prevention & control
Lead Poisoning -- therapy
Medicaid
United States

554. 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

555. 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

556. 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

557. Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies: guidance for industry, investigators, and institutional review boards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Clinical Trials as Topic
Disasters
Emergencies
Government Regulation
Public Health
United States

558. 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

559. 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.

560. Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Forms as Topic
Government Regulation
Product Surveillance, Postmarketing
United States
United States.
United States.

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