FDA Readies Digital Health Pre-Cert Program For Lift Off
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.
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Shuren: FDA Making ‘Pre-Cert Simulator’ To ‘Test Drive’ Regulatory Frameworks For Digital Health Tech
US FDA device center director Jeff Shuren said on 6 October that the agency is developing a “precertification simulator” that will allow it to assess different regulatory frameworks in the digital health space.
In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.
Scott Gottlieb's FDA continues to push out policy reforms and experiments at a rapid pace, with special focus on digital and AI technologies. In parallel, US Medicare officials are more publicly signaling plans to roll out policies for a quicker path to reimbursement for new devices. However, public scrutiny of whether device regulations properly protect patient safety is growing, and it could have an impact.