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.
The proposed rule also would clarify that Part 3 procedures apply to those products whose classification is in dispute. Sponsors are often uncertain whether they must ask for a classification or assignment determination before making a premarket submission for the product if the classification is clear. The proposed rule would clarify that the Part 3 procedures are unnecessary in such cases.
The rule also outlines steps to bring Part 3 more in line with legislative and regulatory actions adopted since it was implemented in 1991. In 2005, the FDA clarified the meaning of “proposed mode of action” for assignment of combination products. In 2009, the Biologics Price Competition and Innovation Act amended the definition of “biological product mode of action.”
Read the proposed rule here: www.fdanews.com/05-14-18-Rule.pdf. — Zack Budryk