Intrinsic Imaging is an FDA Audited medical imaging core lab team providing services in support of Phase I-IV Clinical Trials and Medical Device Trials.
This FDA audit was a routine audit in relation to Intrinsic Imaging providing medical imaging core lab services for a large Phase III clinical trial for a premarket approval (PMA) of a Class III medical device for the diagnosis of breast cancer.
During this trial, Intrinsic Imaging provided imaging core lab services, clinical trial expertise and 12 board-certified subspecialized radiologists to evaluate this clinical trials primary endpoints. Intrinsic Imaging processed over 4,300 images, radiologic evaluations and associated case report forms.
FDA Audit Result – Full Compliance – Zero 483
During this 5-day audit, the FDA thoroughly inspected Intrinsic Imaging’s entire quality management system (QMS). They also audited all clinical trial data to ensure compliance with all federal regulations.
Intrinsic Imaging was found to be in complete compliance with all federal regulations and received Zero 483 observations from the FDA.
Subsequently, the FDA granted premarket approval (PMA) of this Class III medical device. Premarket approval of Class III medical devices is the most stringent type of device marketing application required by the FDA.