Final Guidance Describes Risk-Benefit Factors for FDA Enforcement Actions

The FDA has provided new clarity for industry regarding the risk-benefit factors the agency may consider in prioritizing resources for medical device compliance and enforcement.

Manufacturers can use the same risk-benefit factors when choosing their responses to nonconforming product or compliance issues, the final guidance says.

When the FDA assesses device benefits, it considers the type of benefit; likelihood of patients experiencing benefits; duration of effects; patient preference; benefits for healthcare professionals or caregivers; and medical necessity.

Risk considerations include severity, categorized into three levels: deaths or serious injuries, non-serious events or events without reported harm; likelihood of risk; nonconforming product risks, such as how many nonconforming devices are on the market; duration of exposure; false-positive or false-negative results; patient tolerance of risk; and risk factors for healthcare professionals.

The final guidance clarifies some of the examples in the draft guidance (IDDM, June 17) and provides additional examples to show how the FDA considers risk-benefit factors affecting product availability decisions. The new examples include a malfunction of a pregnancy test with low benefit and moderate additional risk, and a recall of a radiation therapy device with high benefit and increased risk for some patients.

The final guidance also encourages manufacturers that wish to provide information on benefits and risks to do so through the designated FDA point of contact for the issue being assessed, spokeswoman Deborah Kotz said. For example, a district recall coordinator would be the appropriate point of contact in the context of a potential recall.

Read the final guidance here: www.fdanews.com/12-29-16-Benefit-RiskGuidance.pdf.