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Who regulates your products? – Elexes
Elexes Medical Consulting

The first step towards bringing your product to the market is understanding which center at the FDA shall regulate your product. The primary centers: 

  • CDRH – Center for Devices and Radiological Health
  • CDER –  Center for Drug Evaluation and Research
  • CBER – Center for Biologics Evaluation and Research

While for most products a categorization between drugs, biologics, and medical devices is easy, in some cases this can be a challenge, especially if a product is a consumer product or mobile app with medical application or a combination product, injection, drug delivery system, etc. However, if one asks the following simple questions, this distinction can be easy: 

  1. How would you define your product – meets the definition of a drug, a biologic or a device?
  2. What is the primary mode of action of your product? 
  3. What category you think it should be under – sometimes the category that you might think first would not be the right one, so review w.r.t. indications for use and competitors.  

The right center will allow you to hire the right regulatory expert to help navigate through the regulatory process and efficiently get to the market and maintain compliance henceforth.


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