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Auditing of Medical Device Trials

1 credit


Full course description

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.


Principles of auditing and monitoring in medical device clinical trials will be discussed.Topics unique to medical device trials will be examined, e.g., significant risks, IDE exemptions, and device modifications.Current issues identified by the FDA including warning letters, device trial monitoring and risk evaluation, and implementation of risk-based monitoring and auditing in medical auditing concepts will be explored.


  1. Monitoring, Auditing and Inspections
    • Auditing
      • FDA Bioresearch Monitoring Program Information (BIMO)
      • Inspection types
      • Evaluation criteria
    • Inspections
      • Exit interview
      • Form FDA 483- issued post-inspection for violations of the Food Drug and Cosmetic (FD&C) Act
      • Warning letter example
  2. Comparison of monitoring, auditing, and inspection visits
    • FDA inspection/audit visit
    • Sponsor site auditing/monitoring visit
    • Internal monitoring visit
    • Pre-study qualification visit
    • Site-initiation visit
    • Monitoring visit
    • Close-out visit
  3. Audit Checklist
  4. Three unique features of medical device trials
    • Significant risks
    • IDE exempt from quality system regulations
    • Device modifications based on risk: benefit
      • 21 CFR 812 – Investigational Device Exemptions
      • IDE requirements/ permits/exempts for human study
  5. Warning Letters since 2013
    • Failure to ensure that an investigation was conducted in accordance with the investigational plan
    • Failure to ensure that informed consent is obtained in accordance with Part 50 [21 CFR 50.27(a)]
    • Failure to maintain accurate, complete and current records [21 CFR 812.140(a)(1)] and [21 CFR 812.140(a)(3)]
  6. Risk-based monitoring of medical device clinical trials
    • On-site and centralized monitoring
    • Alternative monitoring techniques
  7. Clinical monitoring with quality


C. Benson Kuo, PhD, RAC, is the Associate Director of the Consulting Center in the Regulatory Science program and Assistant Professor in the Titus Family Department of Clinical Pharmacy and Pharmaceutical Economics & Policy at USC. He acts as consultant for regulatory compliance, submission requirements, and strategic planning for innovative products developed at USC or by community members. Prior to joining the program, he served as the regulatory affairs manager at Alfred E. Mann Institute, responsible for regulatory support of medical device development and regulatory submissions and compliance with the FDA and IRBs. Before embarking on his regulatory affairs career, he worked in biotech industry and served as bioinformatics scientist, patent scientist and patent agent.  Dr. Kuo completed his PhD in the field of biomedical sciences and received postdoctoral training at the Stanford University School of Medicine. He is a graduate of the Regulatory Science program and RAC-certified by the Regulatory Affairs Professional Society (RAPS). He is a member of RAPS, OCRA (Orange County Regulatory Affairs Discussion Group), and the Southern California Clinical and Translational Science Institute (SC CTSI) Regulatory Knowledge & Support (RKS)



This symposium is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience.Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.

Learner Level: Beginner

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.Attendees to this CNE activity will be awarded 1.0 Continuing Nursing Education contact hours from ENPDC.

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Program Information: This is the sixth course in a seven session program. To complete the entire program and earn badge Click Here.

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