A product's Intended Use, Indication for Use, and Mechanism of Action (MOA) are critical factors that determine its regulatory classification—whether as a medical device, pharmaceutical, or consumer product.
For example, a crib mattress with an innovative design might initially be classified as a consumer product. However, if claims are made that the mattress reduces the risk of Sudden Infant Death Syndrome (SIDS) by encouraging infants to sleep on their backs, the product could fall under medical device regulations.
Clearly defining these elements early in development not only shapes your product's regulatory pathway but also helps avoid costly missteps and delays in bringing your product to market.
Your product's technology and how it achieves its intended use are key factors in determining whether it will be regulated as a medical device, drug, biologic, or tissue product. Regulatory classifications can vary significantly across regions—a product considered a medical device in the EU or UK might be classified as a drug in the United States. The critical factor is how the product interacts with the human body to achieve its intended purpose. Understanding and clearly articulating these interactions is essential for navigating global regulatory pathways efficiently and avoiding unnecessary hurdles.
RQMIS Services include:
- FDA Request for Designation (RFD)
- FDA PreSubmissions
- FDA, Notified Body and Competent Authority Negotiations
RQMIS makes sure that your production strategy is seamlessly integrated with your regulatory pathway, setting the stage for efficient approvals and successful market entry.