FDA Inspections

FDA Inspection – AI/CAD Medical Device

In August 2012, Intrinsic Imaging underwent an extensive 5-day high priority Bioresearch Monitoring Program (BIMO) inspection by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER).

Intrinsic Imaging was in complete compliance and received zero 483 observations from the FDA.

This inspection was related to a pivotal study of a new Artificial Intelligence / Computer Assisted Detection (CAD) software for breast cancer.

During this successful inspection, the FDA audit included a review of all clinical trial documentation, standard operating procedures, training records, facilities, resource and subcontractor management records, corrective and preventative action documentation, computer software qualifications and internal audit documentation.

The agency also inspected quality control procedures, equipment maintenance logs, back up and disaster recovery plans, image and data transfer procedures and the company’s compliance with 21CFR11 electronic records and electronic signatures regulations.

FDA BIMO Inspection – Epithelial Cancers

In August 2018, Intrinsic Imaging underwent an extensive 5-day high priority Bioresearch Monitoring Program (BIMO) inspection by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER).

Intrinsic Imaging was in complete compliance and received zero 483 observations from the FDA.

This inspection was related to a pivotal study of a new biologic license application (BLA) in patients with various advanced epithelial cancers.

During this successful inspection, the FDA audit included a review of all clinical trial documentation, standard operating procedures, site training and qualification records, image transmittal forms, radiologist RECIST determinations, case report forms, and adjudication determinations.

At the conclusion of the inspection, the FDA inspector highly praised Intrinsic Imaging’s quality management system. In particular, the inspector highlighted the robustness of their quality control process to ensure the accurate data transfer of independent reviewer assessments to the sponsor.