Combination products are overseen by the Food and Drug Administration or the FDA, as mentioned in the video. So, how does the process work, and what can people expect from the FDA regarding oversight and regulation practices?
The FDA guides the process of combining and which constitute parts are involved. The regulatory pars must be retained in the combination process, whether it’s a drug or a device, and must be maintained after combination. So, how does the FDA define combination products?
Combination products are a device drug or combination of both that are used together to create an approach to treatment or medicine. However, each is regulated separately according to previous specifications and guidelines.
Even after combination, each part of a drug or device keeps its designation and status. That means each component is viewed as separate even when combined. Therefore, the CGMP requirements continue to apply to each portion of the combination even after they are combined to make a new device or product.
This also applies to instances where a device and a drug are combined. Each CGMP for the separate components must follow the original specifications before combining.
The FDA is the governing body that oversees combination products such as treatments or medicines. Each component is governed desperately to ensure quality and consistency.