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Start Over Collections Health Policy and Services Research ✖ Subjects Equipment and Supplies ✖

1. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017
Subject(s):: Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
Data Collection
Data Interpretation, Statistical
Decision Making
Device Approval
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 5, 2017
Subject(s):: Device Approval
Equipment and Supplies
Insurance Coverage
Medicare -- economics
Therapies, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Centers for Medicare & Medicaid Services (U.S.)

3. Clinical emergency: are you ready in any setting?

Publication:: [Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2010
Subject(s):: Disaster Planning
Emergencies
Equipment and Supplies
Health Facilities
Inservice Training
Humans
United States

4. Unique device identification: Policy regarding compliance dates for class I and unclassified devices, direct marking, and Global Unique Device Identification Database requirements for certain devices : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, July 25, 2022
Subject(s):: Databases as Topic
Equipment and Supplies
Government Regulation
Product Labeling
United States
United States. Food and Drug Administration

5. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Equipment and Supplies
Materials Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Biocompatibility testing of medical devices: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Equipment and Supplies
Materials Testing -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. 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

9. Medical devices

Author(s):: White, Robert S., author
Publication:: [Toronto, Ontario] : Thomson Reuters, 20-December-2021
Subject(s):: United States
Device Approval
Equipment and Supplies
Artificial Intelligence
Medical Device Recalls
United States

10. Unique Device Identification System: form and content of the unique device identifier (UDI) : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, July 7, 2021
Subject(s):: Equipment and Supplies
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

11. Certain ophthalmic products: policy regarding compliance with 21 CFR part 4

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):: Administration, Ophthalmic
Equipment and Supplies
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

12. Medical devices

Author(s):: White, Robert S., author
Publication:: [Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):: Device Approval -- legislation & jurisprudence
Equipment and Supplies
Medical Device Legislation
Computer Security
Equipment and Supplies -- supply & distribution
Equipment Failure
Equipment Reuse
Equipment Safety
Liability, Legal
Medical Device Recalls
Humans
United States
United States. Department of Health and Human Services.

13. Business practices

Author(s):: Steiner, David J., author
Publication:: Toronto, Ontario : Thomson Reuters, 23-December-2019
Subject(s):: Commerce
Drug Industry -- legislation & jurisprudence
Equipment and Supplies
Legislation, Drug
Analgesics, Opioid
Crime
Equipment Failure
Equipment Safety
Federal Government
Fraud
Medical Device Recalls
Opioid-Related Disorders -- epidemiology
Patents as Topic
Prescription Drug Diversion
Humans
United States

14. 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

15. 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

16. 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

17. Indian Health Service: Many federal facilities are in fair or poor condition and better data are needed on medical equipment : report to congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, November 2023
Subject(s):: Equipment and Supplies
Facility Regulation and Control
Government Regulation
Health Facility Administration
Health Facility Environment
Legislation, Medical
United States
United States. Indian Health Service