FDA pre-submission process for modern heart biopsy

Important results from the project

Yes. The goals were met: we prepared and submitted the Pre-Sub materials, conducted the interaction with the FDA, and received written feedback clarifying the regulatory pathway and the requirements for studies and documentation. The team’s capability was strengthened through workshops and process documents, especially for the CEO. No unexpected results emerged, but important secondary effects include strengthened documentation and study design and an updated plan for the STeP application.

Expected long term effects

The project is expected to deliver a clearer regulatory roadmap and strengthened internal capability, shortening time to FDA/CE and accelerating market entry. It enables faster clinical adoption of safer heart biopsies, with fewer complications, shorter hospital stays, and improved diagnostics, especially for patients with smaller anatomy, including many women and children. In the long term, lower healthcare costs, more efficient resource use, and reduced environmental impact are expected.

Approach and implementation

All technical, preclinical, and risk documentation was inventoried and quality-assured. A Pre-Sub package (CDRH premarket review submission cover sheet, device description, intended use, data summary, clinical background, protocol synopsis, and specific questions) was then prepared and iterated in workshops with Microcardix. FDA’s written feedback was analyzed and translated into an action plan and updated study design. In parallel, the team was trained in the FDA process.