A product's Intended Use, Indication for Use, and Mechanism of Action (MOA) will have the biggest impact on how your product will be regulated (a medical device, drug, consumer product, etc.). For example, a crib mattress with a unique design may be treated as a consumer product (not a medical product) until you decide you want to claim that the product reduces the chance of sudden infant syndrome (SID) by encouraging the infant to sleep on its back.
RQMIS can work with you to determine how to best define your product's Intended Use and Indication for Use, as well as determine how the product's MOA achieves the intended use so as to minimize regulatory impact.
Your product's technology and how it achieves its intended use will define whether the medical product is regulated as a device, a drug, a biologic, or tissue. A medical product viewed in the EU/UK as a device can be viewed in the United States as a drug. How the product interacts with the human body to achieve its intended use is what will drive the regulatory decision.
RQMIS Services include:
- FDA Request for Designation (RFD)
- FDA PreSubmissions
- FDA, Notified Body and Competent Authority Negotiations