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The agency released a draft of appraisal questions. “I think right now the system that we are contemplating is a little bit over the top,” Thompson said. “I look at the assessment model and I see 150 questions on the website. I think that is a lot. That would be burdensome for companies. Would they do it? Well, they might if that made [the devices] freely flow to market.” Those 150 draft appraisal questions ask everything from “How does your organization prioritize a culture of proactivity?” to more concrete questions like “How do you leverage real-world evidence in improving patient safety?” Multiple workshop attendees have commented that translating ideas and theories into metrics is difficult. There has also been some difficulty putting the terminology from multiple companies and agencies into a common language. “One of the challenges has been terminology,” Howard Look CEO of Tidepool, a company currently in the Pre-Cert pilot program, wrote in his blog post. “Regulatory Professionals often use different language than software people, so we've been working hard to use terms that software team will understand. A software engineering team at a small startup should be able to read and understand what they need to do to deliver software that will benefit public health.” There has also been a lot of discussion around making the program fair for companies of any size. “I think that is an extremely challenging issue and I don't know if the FDA has fully grappled with that,” Thompson said.
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