Real-world device data may be suitable to support clearance or approval of a new device or expanded indication, but controls to mitigate bias and ensure data is sufficiently relevant and reliable are a must, US FDA conveys in a final guidance posted Aug. 30.
Applying Real-World Device Data: US FDA Finalizes Its Thoughts
The agency issued a final guidance spelling out reasonable applications of real-world device evidence and what factors must be considered when weighing whether data collected from routine care via means – such as electronic patient records or insurance claims – can help support a product approval or other regulatory decision.
More from Regulation
More from Policy & Regulation
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.