BIORESEARCH MONITORING
&
IN VITRO DIAGNOSTIC DEVICES

Presented by
Jean Toth-Allen, Ph.D.
Biophysicist/Consumer Safety Officer
Division of Bioresearch Monitoring

[Powerpoint]

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

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.

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

Responsibilities

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

Inspections & Audits

Team Approach

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

Inspections and Audits

Who

• Clinical Investigators
• Sponsors
• Institutional Review Boards (IRBs)

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

21 CFR Part 812

• Significant risk studies
• Non-significant risk studies
• Exempt studies

Exempt Studies

21 CFR 812.2(c(3)

• 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

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

Human Subject Protection

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

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

Compliance Programs

CP 7348.809 – Institutional Review

CP 7348.810 – Sponsors, Contract Research Organizations, and Monitors

CP 7438.811 – Clinical Investigators

Compliance Programs

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

CDRH BIMO Web Site

http://www.fda.gov/cdrh/comp/bimo.html