09.16.14
Combination products incorporate two or more medical product types to provide novel or improved solutions to healthcare problems for better patient outcomes. But this unique combination of technologies does not always face a clear regulatory pathway.
Determining something seemingly as simple as whether the product should be regulated as a drug or a device can be challenging. This simplistic division does not recognize the unique properties of drug-device combination products nor the potential technical challenges involved in the manufacturing process. Manufacturers of combination products need to consider the design and development of both the drug and device components, as well as the interaction between the two.
This article outlines the regulatory environment for combination products as well as how supply chain security and management—specifically related to raw materials suppliers—will help ensure regulatory compliance and mitigate risks.
Determining something seemingly as simple as whether the product should be regulated as a drug or a device can be challenging. This simplistic division does not recognize the unique properties of drug-device combination products nor the potential technical challenges involved in the manufacturing process. Manufacturers of combination products need to consider the design and development of both the drug and device components, as well as the interaction between the two.
This article outlines the regulatory environment for combination products as well as how supply chain security and management—specifically related to raw materials suppliers—will help ensure regulatory compliance and mitigate risks.