REGULATORY DECISION-MAKING FOR MEDICAL DEVICES: FDA ISSUES DRAFT GUIDANCE
Benjamin (Benny) Arazy
Advanced Medical Technology & Best Medical Practices Must Be Available To All Patients & Physicians Around The World.
The US Food and Drug Administration (FDA) has released a draft guidance document on the use of real-world evidence to support regulatory decision-making for medical devices.
The document clarifies how the FDA determines that real-world data may be sufficient for use in pre-market and post-market regulatory decisions, without changing the evidentiary standards it uses to make those. It also explains how the FDA plans to evaluate real-world data to determine whether it may be sufficiently relevant and reliable for various regulatory decisions, as well as clarifies when an Investigational Device Exemption (IDE) may be needed to prospectively collect and use real-world data for purposes of determining the safety and effectiveness of a device.
The FDA is welcoming comments regarding the draft guidance, which can be viewed here. The notice of availability will be published in the Federal Register on July 27, 2016, and the docket for receiving comments will be open for 90 days from then.
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