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Compliance In Focus
Posted by John Lehmann on Wed, Apr 4, 2012

How Does the FDA Make Benefit-Risk Determinations?

Dice PhotoA new guidance was released this month by the FDA detailing risk-benefit determinations in de novo Process and Premarket Approvals (PMAs) for medical devices. According to the FDA, the guidance fittingly titled: “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” is intended to provide greater clarity on the FDA’s decision making process with regard to assessing the probable benefit of a device versus its probable risk.

For background, here are some key points to each process found on the FDA website:

  • PMA is the most stringent type of device marketing application required by the FDA and approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s)
  • de novo provides a route to market for medical devices that are low to moderate risk, but that have been classified in class III because FDA has found them to be “not substantially equivalent” to predicate devices

The FDA stated the intent of clarifying their decision making processes to improve the predictability, consistency, and transparency of the review process for applicable devices. This fits in with the FDA’s Transparency Initiative, which aims to open the doors of the agency making information on processes more readily available.

Included in this particular guidance is a worksheet which reviewers will use in making benefit-risk determinations for devices. According to the guidance, “this level of documentation is very helpful to maintaining the consistency of review across the different review divisions and better assuring that an appropriate decision is reached.” The guidance also includes helpful hypothetical examples to help further in understanding the risk-benefit thought process.

What do you think of the new guidance? Do you have any unanswered questions about the PMA or de novo process? Let us know your thoughts.

Photo Credit: woodleywonderworks

Topics: Benefit-Risk Determination, FDA

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