MAUDE Review FDA Request

A client pre-submitted a product to the FDA, and asked for a meeting to discuss a new diagnostic medical device being developed for market release. The FDA reviewed the device, and requested that the company added a critical task to the risk analysis for user testing for validation evidence. 

Lack of combined path to market was slowing down the go to market strategy. Moving into the pilot without the expectation of changing the design deemed formative testing irrelevant. The risk documentation was written incorrectly, and all three items were pressing. The FDA requested this without reviewing the device URRA, device end users, and compared the device to an existing diagnostic device that was not comparable to the system presented to the FDA.  

In order to be compliant with their ask the client and we discussed non-validation based responses to the FDA.  AKA go to market strategy.

-The client did not know the critical task that FDA wanted referenced was not a risk for the product. 

-We suggested a quantitative research report of MAUDE to demonstrate compliance to the FDA request.

-Utilizing RStudio a MAUDE review was conducted. Code was created to analyze the hypothesis. 

-This document is now supporting the Validation activities for the whole system. Design Quality Assurance also used it as a reference point to all risk management documents.

-This document complied to the FDA’s request and quantified their hypothesis was not supported.