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1. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Centers for Medicare & Medicaid Services (U.S.)

3. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. 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
United States
United States. Food and Drug Administration

5. 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
United States
United States. Department of Health and Human Services
United States. Department of Homeland Security
United States. Food and Drug Administration

6. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

11. Evaluation of devices used with regenerative medicine advanced therapies

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019

Subject(s):

Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

12. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

13. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

14. Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, March 27, 2020

Subject(s):

Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

15. The least burdensome provisions: concept and principles : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, February 5, 2019

Subject(s):

Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

16. Considerations for the development of dried plasma products intended for transfusion

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, December 2019

Subject(s):

Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

17. Marketing clearance of diagnostic ultrasound systems and transducers: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, June 27, 2019

Subject(s):

Device Approval
Transducers
Ultrasonography -- instrumentation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

18. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019

Subject(s):

Cost-Benefit Analysis
Device Approval
Equipment and Supplies -- classification
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

19. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019

Subject(s):

Clinical Trials as Topic
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

20. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

Publication:

Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019

Subject(s):

Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

21. 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, February 13, 2020

Subject(s):

Atherectomy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

22. 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

23. Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, March 3, 2020

Subject(s):

Device Approval
Suture Anchors
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

24. 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020

Subject(s):

Device Approval
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

26. 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

27. 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

28. 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

29. Regulatory requirements for hearing aid devices and personal sound amplification products: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022

Subject(s):

Device Approval
Government Regulation
Hearing Aids
United States
United States. Food and Drug Administration

30. 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

31. Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022

Subject(s):

Clinical Studies as Topic
Device Approval
Government Regulation
United States
United States. Food and Drug Administration

32. Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 22, 2022

Subject(s):

Device Approval
Government Regulation
United States
United States. Food and Drug Administration

33. 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

34. Principles of premarket pathways for combination products: guidance for industry and FDA Staff

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, January 2022

Subject(s):

Biological Products
Device Approval
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

35. 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

36. 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

37. 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

38. 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

39. 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. Safer technologies program for medical devices: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021

Subject(s):

Device Approval
Equipment Safety
Voluntary Programs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

41. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021

Subject(s):

Device Approval
Formative Feedback
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

42. Medical devices

Author(s):

White, Robert S., author

Publication:

[Toronto, Ontario] : Thomson Reuters, 20-December-2021

Subject(s):

Device Approval
Equipment and Supplies
Artificial Intelligence
Medical Device Recalls
United States
United States. Food and Drug Administration

43. 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.

44. 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

45. 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

46. 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

47. 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

48. 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.

49. 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

50. 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