In a Federal Register Notice scheduled to publish on Monday August 9, 2021 (see prepublication notice here), FDA indicates “[O]n April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021). The U.S. Government has decided not to appeal this decision.”
The issue has to do with the FDA’s long-held position that radiologic contrast agents met the definition of drugs and classified them as such. However, as explained in the notice, in discussing the deciding factors in the Agency’s classification of products: “[A] medical product meets the device definition if it (1) is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, and (2) does not achieve its primary intended purposes through chemical action within or on the body, and (3) is not dependent upon being metabolized for the achievement of its primary intended purposes.” Numbers 2 and 3 are where and why the court said that the Barium Sulfate contrast agent was a device and not a drug.
Because the Agency decided not to appeal the court’s decision, they will need to look at and change the classification of some products that were previously approved as drugs and transition them to devices status. This does have some broad implications and will take time. For instance, firms will need to change their labeling to comply with the device regulations, will have to bring their facilities into compliance with the quality system regulations, prepare for device inspections, and deal with other regulatory issues that are different between the two product classes.
One big additional item that will impact all the products that will be transitioned is the different user fee scheme for drugs vs devices and the current fees that may apply to these products. Drug User Fees that currently apply will have to be transitioned to the Medical Device User Fees and, since current fees are due October 1, 2021 for FY 2022, FDA is advising firms to pay the current recommending drug user fee that applies to the product and request a refund if their product is transitioned. FDA notes that, due to the timing of the court decision, it will not have time to transition products or adjust the fees prior to the fee due date. Other issues that can have a substantial impact on companies apply to the Program Fee that is assessed under GDUFA which is based on the number of approved ANDAs the firm has at the time the fees are due. Some Applicants may fall to a lower tier if some of their ANDAs become medical devices.
The Agency is asking stakeholders to provide suggestions on the amount of time that will be reasonably needed to accomplish transition of their approved products from drugs to devices. The Agency says it will develop an orderly process for the transition of products and will communicate further with stakeholders as they finalize such plans. There will likely be some hidden bumps along the way as the process is flushed out and as FDA hears from stakeholders. The FR Notice states that “FDA currently anticipates that it will publish in a future Federal Register notice a list of approved drug products that we tentatively determine should transition to device status under Genus. Stakeholders would then have an opportunity to comment on those tentative determinations before classification determinations are made.” Hold onto your hats, there is likely going to be some confusion along the way.