Arlington, Virginia, May 30, 2024 (GLOBE NEWSWIRE) — 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 established by the Food and Drug Administration.
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. 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 will help them ensure that the medical devices they bring to market will benefit patients. AAMI TIR48:
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 guidance document 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.
Experienced Healthcare Executive Brings Extensive Financial and Operational Expertise to Cutera Board of DirectorsBRISBANE, Calif.--(BUSINESS…
Roland Rott, the current president and CEO of Ultrasound, will lead Imaging, replacing Jan Makela…
NEW YORK, June 10, 2024 /PRNewswire/ -- The global glass lens market size is estimated to grow…
NEW YORK, June 10, 2024 /PRNewswire/ -- The global digital pathology market size is estimated to…
Company appoints Pearl Barnett as Chief Operating Officer; Megan Owen becomes Chief Compliance Officer STURGIS,…
MORRISVILLE, N.C., June 10, 2024 /PRNewswire/ -- IEM International, Inc., a global leader in emergency…