FDA Issues Guidance on Real-World Evidence for Medical Devices

Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance on the use of real world evidence to support regulatory decision-making for medical devices. The final guidance follows a July 2016 draft guidance on the topic in which the FDA discussed potential uses of real world data and the various factors evaluated to determine whether that data can support a regulatory decision. The FDA believes that this guidance is a “cornerstone” of its strategic priority to build a national evaluation system for health technology. The final guidance includes clarity as to what it means for companies moving forward, “While FDA encourages the use of relevant and reliable real-world data, this guidance neither mandates its use nor restricts other means of providing evidence to support regulatory decision-making.” In the final guidance, FDA recognizes that “traditional” clinical trials may sometimes be impractical or overly challenging, and appropriate real world data can sometimes provide comparable information. While clinical trials are controlled and require monitoring and data auditing, they may be narrow in scope. Real world data may be able to generate information on a broader patient population, but studies must be carefully designed, regardless of whether the real world data has already been collected or will be collected in the future. Protocols and analysis plans for real world data “should address the same elements that a traditional cl...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs