Software At The Speed Of Trust: US FDA Launches Pilot To Expedite Digital Health Products
Executive Summary
Nine companies are asked to volunteer for a pilot program that could lead to a new pathway for sponsors of digital health products. Under the plan, the agency would allow firms to market a product with fewer if any pre-market review requirements based on trust developed in the company's software design and testing. If the project works out, FDA digital health leader Bakul Patel tells Medtech Insight, the agency hopes it will attract more non-traditional medical device firms that specialize in software development.
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