Transcript BIORESEARCH MONITORING

BIORESEARCH MONITORING
&
IN VITRO DIAGNOSTIC DEVICES
Presented by
Jean Toth-Allen, Ph.D.
Biophysicist/Consumer Safety Officer
Division 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-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)
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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:
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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