Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. In recent years, the FDA has received large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s product centers. 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.
Obtaining the right advice in identifying the appropriate product designation early in the submission process is critical to avoid unnecessary delays and related costs to companies eager to bring their products to market. The attorneys of Rick Ruz, PLLC can provide your business with advice on whether its products are combination products and, if so, assist in obtaining the most beneficial product designation to meet the clients’ individualized goals. To obtain additional information regarding how our firm can help your business, please contact our firm to arrange a consultation.