Gottlieb Unveils Next Steps In Digital Health Plan
The US FDA Commissioner outlined six new updates to the agency's digital health plan, including a new guidance, the next steps for pre-certification and a digital health focus for drugs.
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Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.
In a Medtech Insight exclusive podcast interview, US FDA's Bakul Patel talks about what the agency wants to learn from a newly released "working model" intended to set the initial foundations for the digital health pre-certification program. The first version of the program will start before year's end and he's hoping for industry feedback to prepare for it.
US FDA laid out its proposed starting model to launch the pre-certification program for digital health products, including a matrix for when pre-certified app and software developers could bring new or modified products to market with either streamlined or no pre-market review.