AAMI TIR48, “Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Product,” has just been released. This new publication helps medical device manufacturers and others effectively implement FDA requirements for CGMP (Current Good Manufacturing Practices) with regards to combination products.
What is a combination product? It is a product that integrates a medical device with drug delivery, biological products, or other devices. These types of medical devices are used for therapeutic or diagnostic purposes. The FDA regulation that applies (21 CFR Part 4) became effective on 7/22/2013. So this TIR is timely for industry. Other best practices, guidelines and standards from jurisdictions outside the U.S. are also considered in this publication.
Why did AAMI develop the AAMI TIR48? Issues surrounding combination products and CGMP operating systems have surfaced as industry needs to meet these new FDA requirements. The TIR48 gives you the information you need to make informed, risk-based decisions during development, manufacture, premarket regulatory evaluation, and commercialization of your combination medical devices.
What’s included in AAMI TIR48? The publication starts with a scope clause and then moves directly into how to apply CTMPs in accordance with the FDA’s final rule for combination products (that 21 CFR Part 4 again.) Clause 3 addresses the issue of transitioning to a “streamlined approach” and all that that entails. Clause 4 covers the application of design controls and risk management for combination products. The document is completed by an Annex A on terminology and a 35-item bibliography.
How can you get a copy of AAMI TIR48? Use an authorized standards distributor like Document Center Inc. to make sure your copy is authorized. We provide all AAMI standards in both paper format and for pdf download. Additionally you can include your AAMI standards in our multi-user subscription service, Standards Online.
You can search for and order standards using your browser at www.document-center.com. Here’s a direct link to order AAMI TIR48. Want to know more about our subscription service or have other questions? Contact our staff by phone (650-591-7600) or email (info@document-center.com). We’ve been working with standards since 1982. So make Document Center your Standards Experts!