Medical Device - Product Classification

Determining your medical device or your product’s FDA classification is a key decision that will define its regulatory pathway to the marketplace. Our experienced team of consultants will guide you through the classification process, up to and including developing a Request for Designation (RFD) to the FDA. To determine your product's classification, ask these questions:

• Who will use your medical device / product?
• How do you want people to use your medical device / product? (Intended Use)
• What patient population do you want your medical device / product used in? (Indication for Use)
• What product benefits do you wish to claim? (medical device claims)
• What is your medical device / product’s composition?

Regardless of where you plan to sell or distribute your product, your product's FDA classification is instrumental when designing a strategic plan for the potential regulatory pathway to market. Doing this work up front will ultimately help you achieve your marketing objectives in the selected markets of interest.

Learn more about our Regulatory Pathway Design here.