FDA device review and new guidelines

The U.S. Food and Drug Administration issued new guidelines Tuesday to help device makers understand how FDA reviewers evaluate premarket approval for high-risk devices and de novo submissions for moderate risk devices.

In doing so, the agency reiterated a desire to provide clarity, consistency and transparency to a process that device manufactures have often charged as unpredictable, capricious and confusing.

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“In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Jeffery Shuren, director for the Center for Devices and Radiological Health, in a news release.

The one-of-a-kind guidance — Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications — shows that reviewers look at a multitude of benefits that a device claims to have, including the type of benefit, the magnitude of the benefit, the probability that patients will enjoy one or more of these benefits and how long these benefits will last.

While evaluating the potential benefits, reviewers are also taking stock of possible risks posed by these devices. The factors that influence the risk assessment include the severity, types, numbers and rates of harmful events associated with use of the device, the probability of a harmful event and duration of harmful events among other factors.

Along with issuing the new guidance, the FDA also provided a worksheet for device reviewers that incorporates the main factors that influence the benefit-risk assessment.