Devices

Guidance on Real-World Evidence in Device Decisions

FDA will publish 8/31 a guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, to clarify how the agency evaluates real-world data to determine if they are sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. A Federal Register notice says that because of its nature, the relevance and reliability of real-world data can vary across sources. And, it says, there are many types of regulatory decisions with varying levels of evidentiary needs.

“FDA’s evidentiary standards for regulatory decision-making are not changing,” the notice says. “FDA encourages the use of real-world evidence where appropriate, and will evaluate whether the evidence is of sufficient relevance and reliability to address the specific regulatory decision being considered.”

The agency says the guidance should be used to complement, but not supersede, other device-specific and good clinical practice guidance documents. FDA says it considered comments received on the draft guidance that was published 7/27/16 and then made revisions in response to the comments.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome