BIORESEARCH MONITORING & IN VITRO DIAGNOSTIC DEVICES

1. BIORESEARCH MONITORING&IN VITRO DIAGNOSTIC DEVICES Presented by Jean Toth-Allen, Ph.D. Biophysicist/Consumer Safety Officer Division of Bioresearch Monitoring

2. Branch Responsibilities Program Enforcement Branch I (PEB I) (301) 594-4720 Responsible for neurological, cardiovascular, respiratory, urological, reproductive, gastroenterology, renal & radiological devices Program Enforcement Branch II (PEB II) (301) 594-4723 Responsible for general surgery/hospital, restorative, orthopedic, ophthalmic, dental, ear, nose, & throat, & in-vitro diagnostic devices

3. Program A comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.

4. Objectives • to ensure the quality and integrity of data and information supporting premarket submissions and applications (PMAs, PDPs, IDEs, and 510(k)s) • to ensure that human subjects taking part in investigations are protected from undue hazard and risk

5. Responsibilities • Bioresearch Monitoring • Application Integrity Policy (AIP) • Promotion & advertising of investigational devices

6. Inspections & Audits • Division of Bioresearch Monitoring (DBM or BIMO) • Office of In Vitro Diagnostic Devices Evaluation & Safety (OIVD) • Field (ORA) • Others, as applicable Team Approach

7. Inspections and Audits • Clinical Investigators • Sponsors • Institutional Review Boards (IRBs) Who

8. 21 CFR Regulations Part 809 – In Vitro Diagnostic Products for Human Use Part 812 – Investigational Device Exemptions Part 50 –Protection of Human Subjects Part 56 – Institutional Review Boards

9. 21 CFR Part 812 • Significant risk studies • Non-significant risk studies • Exempt studies

10. Exempt Studies • labeled according to 21 CFR 809.10 • noninvasive • noninvasive sampling or no significant risk • does not introduce energy into a subject • not used as the diagnostic for determination of treatment 21 CFR 812.2(c(3)

11. Significant Risk Determination • If study involves invasive sampling • If results from use of an investigational IVD will determine treatment, could inaccurate results: • be life-threatening • result in permanent functional impairment • result in permanent structural damage • necessitate medical or surgical intervention to prevent impairment or damage

12. Human Subject Protection • 21 CFR Parts 50 & 56 apply to all studies with human subjects • IRB must review allstudies • Expedited review possible • Informed consent • protects subject privacy & confidentiality • facilitates FDA data audits

13. 21 CFR Part 58 ?? • Good Laboratory Practice for Nonclinical Laboratory Studies • to assure quality & integrity of safety data • not applicable to studies with IVD devices – tests regarding safety are clinical studies

14. Compliance Programs CP 7348.809 – Institutional Review Boards CP 7348.810 – Sponsors, Contract Research Organizations, and Monitors CP 7438.811 – Clinical Investigators

15. Compliance Programs http://www.fda.gov/ora/compliance_ref/bimo/default.htm

16. CDRH BIMO Web Site http://www.fda.gov/cdrh/ comp/bimo.html