USA – Self-selection Studies: Guarding against contraindicated use of OTC medical products

Self-selection studies are a type of research that the US Food and Drug Administration often requires manufacturers of over-the-counter (OTC) medical and combination products to conduct. However, in our experience, FDA also sometimes requests self-selection data for OTC combination products and medical devices. Self-selection studies are important for OTC products because a layperson must determine independently (perhaps after receiving some training) whether a product is suitable for them. The shift in responsibility from prescribing healthcare provider to the layperson to make a correct decision “raises the ante” when it comes to ensuring safe and effective use of OTC products, and FDA has enforced special testing requirements for some time now…