Product Classification: Consumer Product versus Medical Device

Choosing the pathway to market is major decision with consequences both in time and money.

The situation: a pediatrician designed a unique mattress design to encourage an infant to sleep on their back. A 510(k) was submitted with the assistance of a consultant. Upon submitting a traditional 510(k) application, the FDA had many questions related to the suggested claim that the crib design mitigated or otherwise prevented Sudden Infant Death Syndrome (SIDS). A treatment claim such as this requires extensive testing and study to prove the claim. The client called RQMIS for help.

RQMIS reviewed the 510(k) and questioned the client as to the claim of SIDS mitigation or prevention. This questioning revealed that the client did not intend to claim SIDS prevention. By eliminating the SIDS claim, RQMIS determined that no FDA approval was required to bring the crib to market. In fact, the crib was simply a consumer product.

RQMIS was able to save this client substantial time, effort and money by eliminating the regulatory requirement to bring the client’s product to market.