Posted: August 5th, 2022

post-approval marketing and recalls and withdrawals.

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Combination products are the last category we will be discussing in this course. The following weeks will be focusing on the broader topics of post-approval marketing and recalls and withdrawals. Combination products are just that, a combination of two or more different types of regulated products as defined by 21 CFR 3.2(e). Combination products can be a drug and a device, a device and a biological product, a biological product and a drug, or a drug + device +biological product. This area can be very complicated for pharmaceutical companies and drug device corporations. The regulatory process is not an easy one to define and is complex at best. So, to have a combination product, a company can spend a significant amount of time and resources on simply the regulatory process to bring their product to market. ********** For this assignment, you are the CEO of a nanotechnology company. You just discovered that you can design nanoparticles that can be placed on the surface of a potato chip to determine if the chip is fresh or stale by turning the chip green if the chip is past its expiration date. You have not done extensive allergenic testing but you believe the allergenic potential is low for this functional food your company has designed. Should you be required to file a food additive petition? Are your nanoparticles considered a new food additive? What about the issue of allergenicity? Do you need to have tests to determine if there is an allergenic nature to the nanoparticles in the potato chips? How does this affect the labeling of your potato chips and are you required to tell the consumer that there are nanoparticles in your functional food? What specific FDA regulations apply to the regulation of food? Nanotechnology? Combination products.

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