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Drug-device combination products are a growing area of product development and regulatory approval. Sterilization of device components is an important issue for these products. The research in radiation chemistry and radiation biochemistry has many obvious applications for the sterilization of devices such as syringes, catheters, tissue allografts and medicines.
Whether it’s a drug-eluting stent or tissue engineering, combination products offer exciting new ways to treat serious diseases and conditions. This includes a range of cancers, heart disease, spinal cord injuries, multiple sclerosis and diabetes. Combination products may require a separate marketing authorization application depending on their constituent parts. A device-drug product with an independent mechanical PMOA would need to be submitted as a medical device, whereas a device-biological or device-chemical combination might be eligible for a biologics license application (BLA) de novo certification or premarket notification (510(k)). Drug Device Combination Product provide new opportunities for safer and more effective treatment, thanks to individualized therapy, precise drug targeting, local administration and advanced drug delivery technologies. However, combination products present unique challenges for product development and regulatory approval. The first question to ask about a medical device or drug-device combination is, what the primary mode of action is. This will determine which regulations the product must follow. Generally, the PMOA of a combination product determines whether it is regulated as a medical device or medicinal product. This determination is based on a statutory definition and the degree of innovation or future use risks of the product. The FDA’s Office of Combination Products (OCP) assigns the audit responsibility for medical device or drug-device combination products to a lead center. Heparin-impregnated catheters would be overseen by CDRH, while drug-eluting stents would be reviewed by CDER. As the stent provides a significant therapeutic impact, while the heparin only has an ancillary effect. Unlike pure medical devices, drug-device combination products require multiple clinical trials to validate their efficacy and safety, as it takes time to understand how the device functions with the drug and what its side effects will be. The FDA also requires that sponsors have a well-defined plan at the design phase so there is traceability from the design review to the final product. The FDA requires sponsor companies to conduct human factors studies in order to ensure that the device can be easily and safely used by patients. A common example of this is a prefilled syringe containing a single dose of medication, which can help reduce errors during self-dosing and improve patient compliance. Lastly, manufacturers of drug-device combination products must comply with all regulations for both the device and the drug. This includes submissions and recordkeeping requirements, such as PMSR. FDA guidance for drug-device combinations explains how to determine which PMSR requirements apply and when. As pharmaceutical, medtech and biotechnology companies innovate in combination product development, there are growing opportunities to enhance patient outcomes through more targeted drug delivery and improved device functionality. However, bringing these innovative products to market is complex and requires a thorough understanding of how to navigate the unique requirements in each regulatory framework. A combination product that includes both a drug and medical device must comply with both the drug CGMPs and the device QS regulations. This can be complicated as manufacturers must have a system in place to ensure that postmarket information from both the drug and device constituent parts of the product are properly fed back to the relevant manufacturing units. Manufacturers of integral DDCs need to include in their marketing authorization application an opinion from a notified body that the device fulfils the EU Medical Device Regulation (MDR) General Safety and Performance Requirements. This requirement is based on Article 117 of the MDR.
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