How to Avoid FDA Design Validation Warning Letters (21 CFR Part 820.30(g)) [Video]

In this warning letter breakdown, we are going to examine how you can avoid design validation citations and how to ensure the correct version of your medical device gets to market.

Reference From Actual Warning Letter

“1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example:

a. The design validation performed on September 21-22, 2016 and documented in the “Customer Usability Analysis” dated January 17, 2017, to demonstrate the ToxCO met user needs and intended use requirements, was performed on units that were not initial production units. The units tested included a firmware version prior to the version implemented. The transferred design used firmware (b)(4) which included several changes including changes to the general user interface based on the results of the Usability Analysis. Your firm has not documented how the devices used in that initial study are equivalent to initial production units or performed a new usability analysis to ensure the device with the updated firmware met customer needs and intended use.”