Black Embrylux will follow the regulatory roadmap below, courtesy of

Device Lab

Product Design Roadmap

Steps to Accomplish

  1.  EVAD is a Class III device with no substantial equivalent
  2. Submit a new application for de novo down-classification
  3. FDA classifies device as low risk
  4. Enter de novo premarket evaluation process
  5. Publish Clinical Trials
  6. Publish Non-clinical Safety Tests
  7. Acquire regulatory approval and certification