AAMI TIR48:2024

AAMI TIR48 – Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products

This Technical Information Report (TIR) provides information about how to effectively implement the FDA’s regulation on current good manufacturing practices (CGMP) for combination products. Combination products are therapeutic or diagnostic medical products that combine drugs devices and/or biological products with one another. The FDA regulation became effective 22 July 2013 (21 CFR Part 4). Final guidance on CGMPs for combination products was issued in January 2017 and a list of alternative or streamlined mechanisms for compliance with CGMPs for combination products was later issued in September 2022 . This TIR where appropriate also considers best practices guidelines and standards used in both the United States and other regions. The overall goal of the TIR is to aid informed risk-based decisions in establishing CGMP operating systems that support development manufacture premarket regulatory evaluation and commercialization of combination products. It should be noted that while the information contained in the TIR has been carefully considered it is up to the individual manufacturer to ensure compliance with all regulatory requirements that apply to its products.