Preparing for a 

FDA IRB Inspecti

Preparing for a 

FDA IRB Inspecti

Presented by Allen Lo

Presented by Allen Lo

Consumer Safety OfficerDivision of Bioresearch MonitoringOffice of ComplianceCenter for Devices and Radiological Health

Consumer Safety OfficerDivision of Bioresearch MonitoringOffice of ComplianceCenter for Devices and Radiological Health
FDA Is Coming!
FDA BIMO Progra

z FDA Bioresearch Monitoring 

program

– To protect human research s

undue hazard or risk

– To ensure the quality and inte

submitted in support of device 

z BIMO inspections
Objectives

z Describe FDA IRB inspectioz Describe inspection proceduz Discuss common inspection

observations and how to resthem

z Provide points to consider
Topics

z Institutional Review 

Board Inspections

z Pre Inspection 

Process

z Preparing for a FDA 

Inspection

z Inspection Dayz What do we inspect?z Inspection Conclusion

z Common 

Deficienc

z Post Insp

Process

z Inspectio

Classifica

z Written Rz Points to z Summary
FDA IRB Inspectio

z A type of FDA inspection designed to re

oversight of FDA-regulated research

z Inspections conducted on-site at an IRBz Inspections typically involve:

– Interviews– Review of policy and procedures– Evaluation of performance via tracke– Facility tours– Determining compliance with regulati– Copying of study records
Pre-Inspection Pro

z Inspection assignments are i

CDRH to district offices

z FDA investigator may pre-an

inspection

z Types of FDA inspections:

-Routine/Surveillance-For Cause/Directed
Inspection Prepara

z Have available

– Most responsible person or designee 

inspection day to accept FDA 482

– Personnel knowledgeable about all a

and the study

– A quiet area to conduct inspection wit

photocopier

z Have available and organized

– All study documents including electro

applicable

– Standard Operating Procedures (SOP
Inspection Da

z FDA personnel (Field Investigato

personnel, etc.) will present his ocredentials

z Issuance of Form FDA 482, Notic

Inspection

z Request that a summary of any in

findings be provided at the end o

z Inspection is conducted during no

business hours
What Do We Inspe

z Policy and procedures z Records of IRB membershipz IRB reportsz IRB approvals and corresponding 

documentation

z Study foldersz Meeting minutesz Significant risk versus non signific

device determination

z Correspondences to and from clin

the sponsor, and FDA
What Do We Inspect? 

z Organizational chartsz Emergency usez Complaintsz Training/Qualification recordsz Collaborative researchz IRB study databases
Inspection Conclus

z FDA Investigator conducts a c

meeting with management

z FDA Investigator issues a For

Inspectional Observations for deviations from the regulation

z Form FDA 483 does not repre

Agency determination

z Opportunity to respond to obs
Common IRB Deficie

z Inadequate meeting 

minutes

z Inadequate/not 

following written procedures

z Failure to have a 

majority of members present during convened meetings

z Inappropriate use of 

expedited review

z Failure to conduct 

continuing review

z Inadequate meeting 

minutes

z Inadequate/not 

following written procedures

z Failure to have a 

majority of members present during convened meetings

z Inappropriate use of 

expedited review

z Failure to conduct 

continuing review

z Failure to 

nonscienduring IR

z Failure to 

IRB mem

z Failure to 

SR/NSR determin

z Failure to 

prompt r

z Failure to 

nonscienduring IR

z Failure to 

IRB mem

z Failure to 

SR/NSR determin

z Failure to 

prompt re
Post Inspection Pro

z The FDA investigator completes Estab

Inspection Report (EIR)

z The EIR, FDA 483 (if issued), support

documentation, and the preliminary disclassification is forwarded to CDRH

z CDRH evaluates the report and determ

classification for the inspection

z Inspection findings and preliminary rec

are reported to the appropriate CDRH 

z Consult with other FDA Centers such 

CDER
Inspection Classifica

z No Action Indicated (NAI)

– No objectionable conditions or find

z Voluntary Action Indicated (VAI)

– Objectionable conditions or finding– But not at threshold to take or reco

administrative or regulatory action

z Official Action Indicated (OAI)

– Serious objectionable conditions fo– Regulatory action recommended
Written Respons

FDA recommends 

your IRB respon

writing to the FDA 
Written Response (c

z An evaluation of the extent of the probz Assessment of the root cause of the pz Any corrective actions 

– Not just a statement that you will co

to correct the problem

– What was corrected?– When was it completed?– Is the problem systemic?

z Preventive actions to prevent recurren

problem in future studies

z Time frame for trainingz Supporting documentation 
Written Response (c

The FDA 483 cited the following: The IRB failed to m

determination for study “ABC”

The IRB provided the following response:

z “We agree that the IRB should have made a risk deter

ABC. A procedure was not in place for determining whinvestigational device initially presented as non significsuch. We have requested documentation from the Spdetermination f

or this particular study and will consult w

preventive action, we have developed and implementethat require IRB members to make this determination fprocedure also gives guidance on how IRB members adetermination. We have performed a risk assessment medical device studies. All IRB members have already procedure. We have attached copies of the procedureforms for ongoing device studies, and training records 6 months, we will conduct an audit of our device studiepreventive action is adequate.”
z Be courteous and responsive to F

personnel.

z Keep study files organized at all tz Maintain ALL correspondence –C

Investigators, Sponsors, and FDA

– letters, faxes, e-mails, memos, 

contacts

z Maintain detailed written procedu

aspects of overseeing research

Points to Conside
Points to Consider (c

If it is not docume

didn’t occu

If it is not docume

didn’t occu
Summary

z Described FDA IRB inspectioz Described the inspection proz Discussed common inspectio

observations and how to respthem

z Provided points to consider