FDA Inspections and Enforcement
BIMO (Clinical) Inspection Readiness
FDA's bioresearch monitoring program inspects the people and organizations that run clinical studies, not the factory. If your device is in a clinical investigation, we help sponsors, CROs, investigators and IRBs get their records, oversight and data ready for that review.
What You Receive
- 01Study Readiness Findings
- 02Device Accountability Reconciliation
- 03Data Traceability Findings
- 04Prioritized Action Plan
Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.
What It Is
BIMO inspections cover sponsors, contract research organizations, clinical investigators and institutional review boards involved in device clinical studies. They follow FDA's BIMO compliance programs, which are separate from the device QMS program used for manufacturing inspections. The questions are different: whether subjects were protected, whether the study followed the investigational plan, and whether the data submitted to FDA can be relied on.
For device studies, the core requirements sit in 21 CFR Part 812 on investigational device exemptions, together with FDA's informed consent and IRB requirements. Inspections look at informed consent records, IRB approvals and correspondence, protocol deviations, adverse event reporting, investigational device accountability, sponsor monitoring, and the trail from source documents to the data in the submission.
Readiness here usually depends on more than one organization. A sponsor's monitoring plan only helps if the monitoring visits were documented, and a site's device accountability log only helps if it reconciles with the sponsor's shipment records. We look at the study as a whole and at each party's records.
When You Need It
- Your study data will support a marketing submission, and FDA may inspect the sponsor or clinical sites.
- You're a sponsor relying on a CRO and have limited visibility into its records.
- Monitoring reports show recurring deviations, consent problems or late adverse event reporting.
- Device accountability records at sites don't reconcile with shipments and returns.
- A clinical site or IRB in your study expects an FDA inspection.
What We Do
- 01
Identify the Parties and Records
We work out who is likely to be inspected (sponsor, CRO, sites, IRB) and which study records each one holds.
- 02
Review Sponsor Oversight
We review the investigational plan, monitoring plan and reports, investigator selection and agreements, IDE correspondence, and how deviations and adverse events were handled.
- 03
Sample Site Records
We sample informed consent documents, eligibility, protocol deviations, adverse event records and device accountability, comparing them with source documents and the sponsor's data.
- 04
Check Data Traceability
We trace selected data points from source documents through case report forms to the datasets behind your submission, looking for breaks in the trail.
- 05
Prepare People and Close Gaps
Study staff practice explaining their records, and findings go into a tracked action plan with owners and evidence requirements.
Deliverables
Study Readiness Findings
Advisor-reviewed findings organized by party and record type, each tied to its source.
Device Accountability Reconciliation
A comparison of shipment, receipt, use and return records across sponsor and sites, with every discrepancy listed.
Data Traceability Findings
Where traceability from source to submission holds and where it breaks.
Prioritized Action Plan
Corrections and preparation tasks for each party, sorted by severity.
How the Platform Helps
Study Records in One Library
Sponsor, CRO and site documents can be uploaded as they are, with original files preserved and duplicates flagged.
Findings That Cite the Record
Each finding points to the document and location behind it, which matters when several parties hold copies of the same record.
Tracked Corrections
Each party's actions carry owners, due dates and evidence the advisor reviews before closing them.
Audits and Inspections It Prepares You For
Standards and Regulations in Scope
Questions About This Service
Is a BIMO inspection the same as a QMS inspection?
No. BIMO inspections follow FDA's bioresearch monitoring compliance programs and focus on study conduct, subject protection and data integrity. QMS inspections of manufacturers follow Compliance Program 7382.850.
Who can be inspected?
Sponsors, CROs, clinical investigators and IRBs involved in the study. Which of them FDA inspects depends on the study and the submission, so we prepare the parties most likely to be involved.
Do device studies follow the same rules as drug trials?
Device studies follow 21 CFR Part 812 for investigational device exemptions, along with FDA's informed consent and IRB requirements. Some expectations overlap with drug trials, but device-specific requirements such as investigational device accountability and significant risk determinations apply.
Can you help if our CRO holds most of the records?
Yes. We can review the records the CRO provides and help you assess your oversight of the CRO, which is likely to come up in an inspection of the sponsor.
Where does ISO 14155 fit?
ISO 14155 covers good clinical practice for clinical investigations of medical devices. Many sponsors build their study procedures around it, and we can read your procedures against it alongside the FDA requirements.
Request an Assessment
Discuss BIMO (Clinical) Inspection Readiness With an Advisor
Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.
