Looking forward to seeing new guidance on the use of RWE to support regulatory decision-making for medical devices in 2024! A timely addition to the docket. High on DTx's wish list for this guidance would be: - addressing the uses of RWE to modify an existing approved Intended Use (e.g. switching from prescription to OTC) - addressing the scenario where a product operating under an enforcement policy seeks to submit a 510k/De Novo and has accrued real-world data along the way Eagerly looking forward to seeing how this one coalesces.
