FDA Submissions including Documentation Preparation

Alira Health assists in advising the company on documentation needed, in preparing submission package and acting as primary correspondent with the FDA, and leading and managing FDA meetings as part of the device submission. The submissions types covered are 510(k), DeNovo, PMA (Pre-Market Approval), Investigational Device Exemption (IDE), Emergency Use Authorization (EUA), Humanitarian Device Exemption (HDE/HUD), CLIA, and LDTs.