Why It’s Important

Whether you are developing a new ingredient, food contact substance, medical device, drug or other FDA-regulated product you must have a plan that will bring your product to market efficiently and at the lowest possible cost.

  • If you don’t do your homework, you could launch your product and then find that you are infringing on an existing patent. At best this could mean that you have to pay a licensing fee. However, it could mean that you have to remove your product from the market and pay damages to the patent holder.

  • Some products are highly regulated; even apparently simple products are subject to at least a few regulations.
  • In some instances there may be laws and regulations affecting the materials you can use or the way you market your product.

Plan Your Regulatory Path

Does your product need to be cleared or approved by FDA before market introduction? Understanding what regulations apply to your technology is a crucial step in the product development process.

“If you don’t know where you are going, you’ll end up someplace else.”
― Yogi Berra

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Ingredient Evaluation

Whether you are developing a new ingredient, food contact substance, medical device, drug or other FDA-regulated product you must have a plan that will bring your product to market efficiently and at the lowest possible cost.

  • Is every ingredient in your product permitted?
  • Are there any pre-approvals that may be required?
  • Does your formulation stay within the defined levels of safe use for each ingredient?

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Required Facts Boxes

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