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Device Clinical Trials and More…

The FDA BIMO Program conducts on-site inspections and data audits to monitor all aspects of FDA-regulated research, ensuring the rights, safety, and welfare of human research subjects, as well as the integrity of collected data.

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Device Clinical Trials and More…

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  1. Device Clinical Trials and More… Michael E. Marcarelli, PharmD Director, Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health US Food and Drug Administration

  2. BIMO Program Description • A comprehensive, Agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.

  3. BIMO Program Objectives • Protect the rights, safety, and welfare of human research subjects • Assure the quality, reliability, and integrity of data collected

  4. FDA Organization Chart PROGRAM ENFORCEMENT BRANCH SPECIAL INVESTIGATIONS BRANCH

  5. CDRH BIMO Program Responsibilities • Regulatory Inspections • Develop and issue inspection assignments • Review and assess EIRs • Determine proper compliance action • Integrity Program - Application Integrity Policy (AIP) - Integrity Hold (IH) • Promotion and Advertising (P&A) • Investigational Devices • Educational outreach

  6. Who does CDRH BIMO Inspect? • Clinical Investigators (CI) • Sponsors/Monitors/CROs • Institutional Review Boards (IRB) • Non-Clinical Labs (aka GLP)

  7. CDRH Inspection Triggers • Marketing application subject to MDUFMA • Novel Technology • Vulnerable Population • Complaint • Surveillance • IRBs

  8. What do we look at? • Compliance programs • 7348.808/9/10/11 • http://www.fda.gov/ora/compliance_ref/bimo/ • Intangibles • FDA Perception • Corporate culture • Oversight and control • Patterns of behavior or failures • Attitude

  9. BIMO Inspections • Section 704 FD&C Act • Generally will call to schedule • What if they don’t? • Credentials/NOI (Form FDA 482) • Use FDA Compliance Program • Inspectional focus • Usually a specific study • Interviews • Document Reviews • Intangibles

  10. BIMO Inspections (cont’d) • INSPECTIONAL FINDINGS • CLOSEOUT DISCUSSION w/MANAGEMENT • SIGNIFICANT OBSERVATIONS (FDA Form 483)

  11. Written 483 Responses • Prompt and adequate responses may be helpful. • Help CIs respond to noted observations.

  12. Written 483 Responses Should Include: • Assessment of the root cause of the problem • Any corrective actions to correct the problem • An evaluation of the extent of the problem • Any preventative actions to avoid recurrence • Supporting documentation • Timelines for implementation

  13. Untitled/Warning letter Re-inspection Informal conference 3rd party audits Rejection of site data Disqualification CI, IRB, or GLP Invoke Application Integrity Policy or Integrity Hold Revoke marketing or research permit Civil Money Penalties Seizure Injunction Prosecution Compliance Tools

  14. CDRH BIMO INSPECTIONSFiscal Years 2002 - 2006

  15. CDRH BIMO INSPECTIONSFiscal Years 2002 - 2006

  16. CDRH BIMO Warning Letters

  17. CDRH BIMO Warning Letters

  18. CDRH BIMO Compliance Rates

  19. CDRH Sponsor Compliance Rates

  20. Most Common CDRHSponsor Deficiencies • Inadequate monitoring • Failure to secure investigator compliance • Inadequate device accountability • Failure to obtain FDA/IRB approval

  21. CDRH Clinical Investigator Compliance Rates

  22. Common Investigator Deficiencies • Failure to follow investigational plan, investigator agreement, or protocol • Protocol deviations • Inadequate subject protection or informed consent • Inadequate device accountability • Lack of FDA or IRB approval

  23. What’s new? • FDA Guidances • Final guidance: Use of Computerized Systems in Clinical Trials • Draft guidance: AE Reporting to IRBs • Draft guidance: Supervisory Responsibilities of Investigators • CDRH • PAS • Pre IDE/PMA

  24. What can be done to modernize clinical trials? • Build quality into each step of the clinical trials process • Utilize a risk-based approach to variation; define acceptable levels • Modify regulatory approaches to enhance continuous improvement • Develop and implement standardization for each step of process

  25. Web Sites Device Advice www.fda.gov/cdrh/devadvice CDRH BIMO site www.fda.gov/cdrh/comp/bimo.html Good Clinical Practices www.fda.gov/oc/gcp/

  26. Contact Information Michael E. Marcarelli, PharmD FDA, CDRH, Office of Compliance 9200 Corporate Blvd HFZ-310 Rockville, MD 20850 (240) 276-0125 Michael.Marcarelli@fda.hhs.gov

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