Successful Medical Device Product Classification

The Situation

A crib manufacturer requested FDA approval of their product due to its unique nature. The submission prompted questions from the FDA related to the suggested claim in the submission.

The Solution

RQMIS reviewed the submission and interviewed the manufacturer. The product did not require FDA approval, and was, in fact, a consumer product.

Choosing the medical device regulatory pathway to market is a 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. An FDA 510(k) was submitted with the assistance of a consultancy company. Upon submitting an FDA traditional 510(k) submission, the FDA had many questions related to the suggested marketing claim that the crib design mitigated or otherwise prevented Sudden Infant Death Syndrome (SIDS). A treatment marketing claim such as this requires extensive testing and study to prove the claim. The client called RQMIS for help.

RQMIS reviewed the FDA 510k submission 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 medical device consultant experts were able to save this client substantial time, effort, and money by eliminating the FDA medical device regulatory requirement to bring the client’s product to market.

Do you need regulatory consultancy service for your medical devices?

Our medical device regulatory consulting expert can help you. We are also a 510(k) submissions expert.

Contact RQMIS at, call us at (978) 358-7307, or just click on the Contact button below.


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