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Product Idea Classification

Xario 200 Diagnostic Ultrasound System

A new medical product concept or a new application of an existing medical product must be evaluated early to determine how your product will be classified and, therefore, regulated by the FDA or the Competent Authority. Depending on the intended use/indication for use the product may not be regulated at all. RQMIS was effective in navigating a client through FDA negotiations to create labeling for a product that allowed them to market their product as a non FDA regulated product. 

For some products, however, it is clear that the technology involved and application chosen will always lead to the product being classified as a device, drug, biologic, or food (including dietary supplements). With the increasing emphasis to develop innovative products that combine two or more of these regulated products into one, a company often finds the regulatory pathway unclear or imprecise. RQMIS recommends to our client that they pose the following questions early in the product lifecycle:

  • What is the intended use? What is the Mechanism of Action (MOA)?
  • What is/are the indications for use/claims? (found in labeling or conveyed orally during sale of product)
  • What is your product composed of? Are any of the compounds included in the product actively regulated as drugs or biologics?
  • Should your product be classified as a drug, device, biologic, or combination product?
  • How does the agency interpret certain key provisions of the definition of product?
  • Should I submit an RFD?
  • Do I understand the differences of the product classification within each geographical market and the effect on regulatory pathway?

RQMIS provides expert guidance and support in assuring clients will thoroughly analyze the answers to these questions and assure the medical product is properly classified. This support includes active negotiation with the FDA or Competent Authority and submission of formal Requests For Designation submissions.