In January 2022, FDA released a new final guidance document titled, ‘Principles of Premarket Pathways for Combination Products’ which has caused many manufacturers to reevaluate their FDA compliance strategies. This document from FDA is not binding law but sets forth FDA’s current thinking on how drug-device combination products will be regulated by FDA going forward and clarifies FDA’s stance on combination-product approvals since the D.C. Court of Appeals decided Genus Medical Technologies LLC v. United States Food and Drug Administration. In that case, the Court of Appeals ruled that, contrary to previous practice, drug-device combination products should be regulated as medical devices, not drugs. This court decision is significant because it potentially opens up new pathways to market for the makers of new combination products.
The new guidance document sets out three compliance routes for combination products, as follows: 1. device-led combination products, 2. drug-led combination products, and 3. biologic-led combination products. Per the guidance document, the primary mode of action (PMOA) of the final product is what will determine how the product will be regulated. This guidance is significant as it incentivizes combination-product designers to use this rule strategically and gain approval by the easiest route. The Office of Combination Products makes the final determination about which route a particular product will follow.
This guidance document will also undoubtedly impact how those in the biopharmaceutical, medical device, and digital health industries choose to design and present their final products. For example, for combination products that are currently regulated as drugs, this will mean big changes to their quality management systems and the applicable regulatory framework that governs their manufacturing operations.
Manufacturers and distributors of combination products should consult with legal counsel and keep an eye on these changes. A misunderstanding of how your product is classified could lead to noncompliance, which can have downstream implications for products liability. These issues can become complicated because some may argue that Genus Medical cannot be used to permit FDA powers to reclassify existing products that are regulated as drugs. Moreover, it will be interesting to see how the PMOA system used by FDA aligns with the opinion set forth by the Court of Appeals. Absent FDA guidance or explanation, such issues will likely only become clear through litigation.