AAMI Releases Guidance on FDA CGMP’s for Combination Products

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As the breadth and scope of combination products around the world continues to ramp up, are U.S. manufacturers equipped with the best design plans possible? A brand-new guidance document, released by the Association for the Advancement of Medical Instrumentation (AAMI), will assist manufacturers in aligning with the latest best practices for manufacturing combination products.  

AAMI TIR48: 2024 Quality management systems (QMS) recommendations on application of the U.S. FDA’s CGMP final rule on combination products is designed to assist manufacturers with abiding by the Food and Drug Administration’s regulation on current good manufacturing practices (CGMPs) for combination products.  

Combination products are defined as products that incorporate drugs or biologics with medical devices. However, the taxonomy and regulations surrounding these products may vary wildly from country-to-country, leading to confusion for manufacturers looking to stay compliant with U.S. requirements. AAMI TIR48 provides a comprehensive resource for manufacturers navigating FDA requirements for combination products and ensuring they can bring medical devices to market that will benefit patients. AAMI TIR48:  

• Assesses FDA’s codified ‘Streamlined Approach’ for compliance with CGMPs and identifies manufacturer considerations.
• Provides a clause-by-clause assessment of the pertinent sections of 21 CFR and identifies compliance pathways.  
• Addresses viable alternative and streamlined mechanisms for complying with CGMPs. 
• Compiles management responsibilities for manufacturers of combination products, addressing aspects such as executive oversight, quality policy, risk based QMS, auditing, and more. 
• Applies design controls and risk management to combination products. 
• Includes information on purchasing controls, corrective and preventive action (CAPA), and inspection readiness for manufacturing facilities.   

AAMI TIR48 was produced by the AAMI Combination Products Committee, which is co-chaired by John Weiner, director of the Office of Global Operations at FDA and Susan Neadle, an industry veteran and leading expert in the field of combination products. According to Neadle, “Sometimes you’re using the exact same words for the drug world as you use in the device world, but the interpretation is different. That creates all sorts of confusion not just for industry but also for health authorities. So, the inspection readiness piece of TIR48 will help you contend with that both internal to your organization and as you’re interfacing with health authorities.”

In short, AAMI TIR48 provides the most current industry guidance for combination products manufacturers as they deal with an increasingly complex regulatory environment. The standard is available for purchase in the AAMI store.  

Questions about the document? Reach out to AAMI at standards@aami.org. Members of the trade press interested in a copy of the guidance are encouraged to reach out at dvisnovsky@aami.org.