When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show ...

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The guidance outlines ...

On December 17, the U.S. Food and Drug Administration (FDA) finalized its long-awaited guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” ...

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...

Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...

Echoing President Donald Trump’s call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from ...

The US FDA will no longer require that identifiable individual patient data be required from applicants when submitting real-world evidence as part of certain medical device applications. Sponsors ...

Regulatory-grade evidence must reflect the true patient experience across care settings over time, supported by transparent, reproducible, and well-governed processes. John Snow Labs’ PJI platform ...

Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...