Combination Product Consulting

Hack & Associates provides clients with assistance in designing and obtaining approval for combination devices.  Hack & Associates can help you determine the primary mode of action for your combination device and determine the appropriate regulatory pathway.  Furthemore, if you choose to combine your device with that of a marketed third party device, we can help you obtain the proper labeling.

Combination Products

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.   Typically, the center that takes the lead review for a combination product is determined by the primary mode of action of that product.  Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.