Attorneys Question Usefulness Of New Combo Products Pre-RFD Process

Industry attorneys are questioning the usefulness of FDA's new process intended to help manufacturers of combination products make an earlier determination of which lead center is responsible for regulating their product. FDA says the new procedure is beneficial because sponsors won't be required to recommend classification, but one attorney worries that this will increase the likelihood of the products being classified as drugs. In an Aug. 11 FDA Voice blog post, Thinh Nguyen, director of the Office of Combination Products...