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Start Over Subjects Device Approval ✖Remove constraint Subjects: Device Approval

1. Health care without the doctor: how new devices and technologies aid clinicians and consumers

Publication:
Oakland, Calif. : California HealthCare Foundation, c2009
Subject(s):
Decision Making, Computer-Assisted
Decision Support Techniques
Delivery of Health Care -- methods
Home Nursing
Internet
Patient Participation
Point-of-Care Systems
Reagent Kits, Diagnostic
Self Care
Allied Health Personnel
Ambulatory Care Facilities
Community Participation
Device Approval
Equipment Safety
Evidence-Based Medicine
Federal Government
Government Regulation
Health Care Sector
Health Policy
Insurance, Health, Reimbursement
Patient Advocacy
Privacy
State Government
Treatment Outcome
Humans
Diagnosis, Computer-Assisted
California

2. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018
Subject(s):
Electronic Health Records
Health Information Interoperability
Logical Observation Identifiers Names and Codes
Reagent Kits, Diagnostic
Device Approval
In Vitro Techniques -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):
Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

5. Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):
Device Approval
Equipment Safety
Morcellation -- adverse effects
Morcellation -- instrumentation
Product Labeling
Leiomyoma -- surgery
Uterine Neoplasms -- surgery
Humans
United States
United States. Food and Drug Administration

6. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017
Subject(s):
Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
Emergency Medical Services
Equipment Safety
Off-Label Use
Public Health
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Food and Drug Administration.

7. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):
Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 29, 2017
Subject(s):
Device Approval
Small Business
Eligibility Determination
Taxes
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. 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.

10. Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 1, 2017
Subject(s):
Advisory Committees -- organization & administration
Device Approval
Equipment and Supplies -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

11. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017
Subject(s):
Equipment and Supplies -- standards
Equipment Design -- standards
Equipment Safety -- standards
Device Approval
Equipment Failure
Information Dissemination
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 12, 2017
Subject(s):
Clinical Trials as Topic
Demography
Device Approval
Research Design
Age Factors
Continental Population Groups
Ethnic Groups
Product Surveillance, Postmarketing
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017
Subject(s):
Device Approval
Papillomavirus Infections -- diagnosis
Reagent Kits, Diagnostic -- standards
Cervix Uteri -- cytology
Cervix Uteri -- virology
Equipment Failure
Equipment Safety
Genotyping Techniques -- standards
Mass Screening
Papillomaviridae -- classification
Papillomaviridae -- genetics
Quality Control
Reference Standards
Reproducibility of Results
Research Design
Specimen Handling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. 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.)

15. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, December 5, 2017
Subject(s):
Computer-Aided Design -- standards
Device Approval
Manufactured Materials -- standards
Materials Testing -- standards
Printing, Three-Dimensional -- standards
Quality Control
Computer Security -- standards
Diagnostic Imaging
Models, Anatomic
Product Labeling -- standards
Reproducibility of Results
Software -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Implantable devices: regulatory framework and reform options

Author(s):
Lind, Keith D., author
Publication:
Washington, DC : AARP Public Policy Institute, August 2017
Subject(s):
Government Regulation
Prostheses and Implants -- adverse effects
Prostheses and Implants -- standards
Clinical Trials as Topic
Device Approval
Equipment Failure
Equipment Safety
Product Surveillance, Postmarketing
Registries
Humans
United States
United States. Food and Drug Administration.

19. Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022
Subject(s):
Diagnosis, Computer-Assisted
Device Approval
Government Regulation
Radiographic Image Interpretation, Computer-Assisted
United States
United States. Food and Drug Administration

22. Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 2020
Subject(s):
Device Approval
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, October 28, 2020
Subject(s):
Defibrillators
Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

24. Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):
Blood Glucose Self-Monitoring
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

25. 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 4, 2020
Subject(s):
Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

28. Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, January 5, 2021
Subject(s):
Biological Assay
Device Approval
Embryo, Mammalian
Mice
Reproductive Techniques, Assisted
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

29. Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices: questions and answers (revised) : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, June 2020
Subject(s):
Device Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

31. Testing and labeling medical devices for safety in the magnetic resonance (MR) environment: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):
Device Approval
Equipment Safety
Magnetic Resonance Imaging -- instrumentation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

32. Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):
Atherectomy -- instrumentation
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

34. Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation: guidance for industry and Food and Drug Administration staff, and other stakeholders

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
Subject(s):
Device Approval
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

35. Patient engagement in the design and conduct of medical device clinical studies: guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
Subject(s):
Clinical Studies as Topic
Device Approval
Patient Participation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

36. Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 23, 2021
Subject(s):
Arthroscopy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

37. Non-clinical and clinical investigation of devices used for the treatment of benign prostatic hyperplasia (BPH): guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 27, 2021
Subject(s):
Device Approval
Prostatic Hyperplasia -- therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

38. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
Subject(s):
Clinical Trials as Topic
Device Approval
Drug Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

40. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Subject(s):
Clinical Laboratory Techniques
Device Approval
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

44. Facet screw systems: 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, April 13, 2022
Subject(s):
Bone Screws -- standards
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

46. Orthopedic fracture fixation plates: 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, April 11, 2022
Subject(s):
Device Approval
Equipment Safety
Fracture Fixation
Orthopedic Fixation Devices -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

47. Technical performance assessment of quantitative imaging in radiological device premarket submissions: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, June 16, 2022
Subject(s):
Device Approval
Technology, Radiologic -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

48. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):
Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

50. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Gastroenterology -- instrumentation
Gynecology
Obstetrics -- instrumentation
Otolaryngology -- instrumentation
Physical and Rehabilitation Medicine -- instrumentation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.