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Drug Eluting Stents (DES)
- 9. The Challenges of Packaging Combination Devices & the Effect of Balloon Material Property on the Life of the Drug Eluting Coronary Stent (DECS) Structure
- 17. The Broad Medical Device Industry Medical Device Testing Electronic Components Metal Components Biomedical Engineering Plastics Components Research Packaging Post-processing
Editor's Notes
- A separate Office of Combination Products (OCP) was established in 2002 to develop regulatory guidelines and compliance systems for products that combine two or more product types.
- It can take hundreds of millions of dollars of research and development, significant funding for clinical trials, and an extensive amount of time to even reach the stage of seeking FDA approval. The regulatory process itself can also be time-consuming as the FDA reviews the volumes of materials and data a company submits in support of its application for approval
- This addresses moisture gain or loss in the package, evaluating extractables and leachables from and to the package, providing full chemical composition of the materials via Drug Master Files (DMF), and a completely different set of product stability requirements. All these requirements may be found in CBER Guidance for Container Closure Systems for Packaging Human Drugs and Biologics, CDER Guidance for Stability Testing of Drug Substances and Drug Products, and USP 661,” a characterization test on plastics. Typically, stability testing on three different batches of packaging materials is performed.” Packaging materials are involved in some instances because some of these products need to be sterile, so how does that have an impact? Previously, maybe you put a device in a package and sterilized the whole thing. Maybe now you’re not able to do that because it has a drug.”