New AAMI Guidance on Combination Products and FDA CGMPs
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 FDA’s regulation on current good manufacturing practices (CGMPs) for 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 FDA’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.
- AAMI TIR48 provides a comprehensive resource for manufacturers navigating FDA requirements for combination products and will help them ensure that the medical devices they bring to market will benefit patients.
- 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.