FDA Should Include More Factors in Risk Calculations, Groups Comment

FDA guidance on risk-benefit decisionmaking in premarket device approvals should include multiple factors for determining whether a device presents low risk, the Medical Imaging & Technology Alliance said in comments on the final guidance.

MITI said the guidance “appears to justify a ‘low’ risk level based on ‘no actual injuries’ from the field or complaints.” The association argued that “rating a risk to be ‘low’ should be based on many other factors such as engineering, scientific and medical evidence.”

For the recommendations to rely on “no actual injuries or death” alone may lead to misclassification of risk levels, the group said. “MITA encourages the FDA to modify the draft guidance and add additional rationale.” — April Hollis