ARTICLE SUMMARY:
CDRH is building a digital simulation system to support rapid modeling of new regulatory paradigms for digital health and, potentially, the broader medtech arena.
New regulatory policies can originate from on-the-ground experiences of regulators, top-down political priorities, or stakeholder recommendations, but FDA is now trying a relatively new approach to policymaking: digital simulations. In a first for the agency, CDRH’s digital health team has created what it is calling the “Precertification Simulator,” an in silico tool for rapidly modeling out the impacts and risks of different regulatory paradigms to fine-tune the most effective approach.
