Industry Praise US FDA Software Pilot Program
Medtech sector representatives say they are optimistic about FDA's plans to accept up to nine companies to participate in a pilot program that could lead to a new pathway for digital health products.
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FDA wants to draw on outside expertise to help it better understand the digital-health industry and to develop its proposed Digital Health Software Precertification Program. The agency is seeking applicants for its Entrepreneur-in-Residence program in the coming months expressly for this purpose.
The US Congress and FDA have established that the agency will only oversee high-risk clinical decision-support (CDS) software, but a key CDS industry groups says too much ambiguity remains. The Clinical Decision Support Coalition has published guidelines in a bid to allow industry to self-regulate as much as possible.
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.