FDA Proposes to Drop Second Appeals for Medical Product Classifications
A process for second appeals of FDA designations for medical product classifications would be eliminated under a new FDA proposed rule.
Part 3 of CFR 21 directs the FDA to assign products that are some combination of a drug, a device and/or a biologic based on the product’s primary mode of action, while non-combination biological products, devices and drugs are assigned within the agency based on their classification.
Under current regulations, sponsors can appeal their classification and make a second appeal if they disagree with the decision, in a process that has been “confusing to sponsors and inefficient for sponsors and agency staff,” the FDA said.
The initial consideration is based on so much data — with no new information allowed to be introduced during appeals — that very few second appeals result in a new classification.