FDA Issues Strategic Guidance on Decentralized Clinical Trials – A Turning Point for Medical Device and IVD Manufacturers

The latest FDA guidance on decentralized clinical trials (DCTs) marks a significant development for IVD and medical device manufacturers. By incorporating digital health technologies, remote monitoring, and home-based device usage, DCTs allow for enhanced trial flexibility and patient accessibility. This guidance clarifies regulatory expectations, especially around investigational product distribution, informed consent, and oversight, supporting innovation while maintaining compliance.