The regulatory designation of a combination product, as a drug, device, or both, has a significant impact on the quality systems adopted as well as the product development and commercial go-to-market strategies. If the combination product is regulated as a device, then its risk classification defines its regulatory and quality strategy.
The increasing complexity of drug delivery systems, discussed above, results in increasing regulatory ambiguities. Navigating this ambiguity is possible by adopting a robust regulatory strategy based on risk-informed scientific practices, especially in the application of performance standards to the combination product. Collective industry experience indicates proactive alignment, transparency, and open engagement with regulators on risk-based approaches to product development, pre-market submissions and lifecycle management results in predictability of outcomes.
The US FDA, for example, has established several pathways for expedited regulatory review and approval of combination products based on both the drug and device primary modes of action (PMOA). For combination products with drug PMOA, these regulatory pathways include the Fast-Track Designation, Breakthrough Therapy Designation, Accelerated Approval, and Priority Review Designation . Similarly for combination products with device PMOA, the regulatory pathways include the Breakthrough Device Program  and the Safer Technologies Program .
As more and more novel therapies and drug delivery systems are developed to address unmet patient needs, thorough yet streamlined reviews and approval of these products is critical in the interest of public health as well as efficient utilization of resources at regulatory bodies which are funded by tax dollars.