Regulatory and clinical strategy for the US market

Important results from the project

The project delivered a clear regulatory and clinical strategy for the US market. Gap analysis and consulting support improved our understanding of FDA requirements and pre-submission preparations. Goals were met, synergies with IVDR work achieved, and internal competence strengthened. The results provide a solid foundation for future paths, including PMA and a possible LDT route via CLIA labs, which creates flexibility and strengthens our market strategy.

Expected long term effects

The project is expected to strengthen Reccan´s long-term opportunities to establish itself in the US market through a clear regulatory and clinical strategy.

Approach and implementation

The project largely followed the planned plan. The activities were relevant and the collaboration with consultants worked well. A change of project manager created some delay as time had to be spent on feedback on previous choices and discussions. Changes in the US regulatory framework also affected the choice of path and took up discussion time, which now includes both a PMA process and the possibility of LDT via CLIA laboratories.