US FDA releases draft guidance on real-world evidence and medical device regulation decisions

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The US Food and Drug Administration (FDA) has released a draft guidance document entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”.

According to an email from the consumer watchdog, the document is intended to clarify “how the FDA determines that real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the evidentiary standards we use to make those decisions.

The email states, “Real-world data, which are collected from sources outside of traditional clinical trials, can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients.”

The draft guidance details how the FDA plans to evaluate real-world data, in order to decide whether it such evidence is sufficiently relevant and reliable to inform regulatory decisions. Giving “generalised” examples of the use of actual real-world data in regulatory decision-making, the document seeks to determine the validity of such data as scientific evidence.

The document goes on to explain when Investigational Device Exemption status might be necessary for the prospective collection and use of real-world data in the evaluation of the safety and effectiveness of a device.

The FDA claims that this guidance document is “a cornerstone of our strategic priority of creating a national evaluation system for medical devices.” This system, the email states, would “build on and leverage the vast amount of data and information collected during the treatment and management of patients.”

The FDA welcomes comments regarding the draft guidance document. The notice of availability is due to be published in the Federal Register on 7/27/16, and the docket for receiving comments will be open for 90 days from that date.

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