BIORESEARCH MONITORING&

IN VITRO DIAGNOSTIC DEVICES

Presented byJean Toth-Allen, Ph.D.

Biophysicist/Consumer Safety OfficerDivision of Bioresearch Monitoring

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-siteinspections 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

• Division of Bioresearch Monitoring (DBM or BIMO)

• Office of In Vitro Diagnostic Devices Evaluation & Safety (OIVD)

• Field (ORA)• Others, as applicable

Team Approach

Inspections and Audits

• Clinical Investigators

• Sponsors

• Institutional Review Boards (IRBs)

Who

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

– 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)

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 Boards

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