CPC Comments on Product Jurisdiction Proposed Rule
Overall, the CPC appreciates the FDA’s stated goals of clarifying the rule, aligning the rule with current statutory language, improving the efficiency of the RFD process, and emphasizing the flexibility and speed afforded by informal processes that are available to sponsors (i.e., the pre-RFD process). However, significant issues remain in this area, including some that are created by this most recent FDA proposal. Such issues continue to create burdensome ambiguity in classifying a product as a drug, device, or biologic, and determining whether the product is considered a combination product. We hope that FDA will consider our comments as it works to finalize the rule.