FDA pre-submission process for modern heart biopsy

Purpose and goal

Microcardix is developing a novel heart cardiac biopsy technology—a medical device that will make heart biopsy a safer and more effective for the management of heart disease. The purpose is to secure a clear regulatory pathway toward clinical approval of Microcardix’s minimally invasive heart-biopsy tool. The goal is to conduct a well-prepared Pre-Submission meeting with the FDA to define required studies and documentation, build internal expertise, and achieve FDA marketing approval.

Expected effects and result

The project will result in a Pre-Sub application and a meeting with the FDA. The FDA’s feedback will clarify regulatory requirements, including necessary studies and documentation. The team will gain expertise in the FDA’s processes and product‐specific expectations. This will shorten timelines and reduce risks on the path to FDA approval, followed by a faster route to CE marking. Ultimately, the project will help the company bring its product to market in a patient-safe and competitive way.

Planned approach and implementation

Project begins with a full documentation review. The consultant drafts the Pre-Sub package (cover letter, device description, data summary, questions) and refines it in workshops with the team. A virtual Pre-Sub meeting is held; minutes and action points are archived. Meanwhile, Microcardix staff receive training in the FDA-process. After the meeting the study plan is updated and the STeP application for the safer-technologies program is completed.