FDA approval process
• InVivage 510(k) submission through the FDA reduced timeframe pathway
• Aim to receive approval for use of images by clinicians, paving the way for follow-up FDA approval
• Submission to take place once all validation, verification and clinical activities are successfully completed
• Following submission, average time to clearance is approximately six months
It looks like InVivage FDA approval could take a while longer than initially thought. Farewell Dr. Currie.
FDA approval process• InVivage 510(k) submission through the FDA...
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