How do I submit a formal request that OCP resolve a dispute regarding the timeliness of premarket review of a combination product?
OCP published a draft guidance document describing the procedures for submission and FDA action on a formal request that OCP resolve a dispute regarding the timeliness of premarket review of a combination product. The document is available at http://www.fda.gov/oc/combination/dispute.pdf. The Medical Device User Fee and Modernization Act (MDUFMA) requires FDA to report annually on the numbers and types of combination products reviewed, and the timeliness of such reviews. Where can I find these data, and how does FDA determine the types of combination products? OCP reports annually to Congress on the numbers and types of combination products reviewed and the timeliness of such reviews. The Reports are posted at http://www.fda.gov/oc/combination/. FDA developed a method to help agency reviewers categorize products under review as to whether or not they concern a combination product, and if so, what type.
