Final Guidance for Expedited Medtech Approval Unveiled by FDA

Friday, April 10, 2015

Source: Smart Brief

The FDA has issued final guidelines on policies designed to expedite the approval of medtech products for irreversibly debilitating or life-threatening diseases without treatment alternatives. Under the Expedited Access Program, firms with such devices can ask the FDA for fast-tracking and would no longer be subjected to the de novo clearance program or the strict process of premarket approval. The FDA said the program also covers breakthrough products that offer "a clinically meaningful advantage over existing legally marketed technology."

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