On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial.
As regulatory processes and reimbursements are refined, there needs to be a continued focus on how to maximize the benefits for patients and ensure DTx can play a role in improving outcomes. The key to this is integration into the clinical workflow.
In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot.
In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to.