BIORESEARCH MONITORING

1
BIORESEARCH MONITORINGIN 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) [phone] 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
Team Approach

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

7
Inspections and Audits
Who

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

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
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

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 all studies
• 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/defau
lt.htm
16
CDRH BIMO Web Site
http//www.fda.gov/cdrh/ comp/bimo.html