Breakthrough Devices Program Submission
The Breakthrough Devices Program supports innovative medical devices that address unmet clinical needs. If accepted, your submission benefits from priority review and enhanced FDA communication.
- Evaluate eligibility and strategic fit
- Prepare documentation to demonstrate unmet needs and breakthrough potential
- Guide the submission process
- Manage FDA communications and responses
Our expert team will position your device for accelerated review and faster time to market.
Trusted by top-tier teams worldwide
Featured case studies
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market. Apotech Consultants One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for…