FDA Bug in the CDRH Databases detected by mdi’s Senior Official – results in an “FDA Letter of Appreciation”

Background
The FDA Total Product Life Cycle (TPLC) database combines data from various CDRH databases (data sources) to present an integrated record of premarket and postmarketed activity for medical devices. A critical bug in the FDA CDRH TPLC database prevented the names of some 510K companies from being displayed appropriately. Apparently the FDA IT team or anyone else was not aware of the bug and how long this bug was in play.

Recently mdi’s senior VP, Susan D Goldstein-Falk, while working one of her numerous 510(k) submissions, identified the critical bug and brought it to FDA notice. The FDA lauded her efforts and perseverance to bring this finding to their attention and work with them to resolve the issue. Susan helped the FDA to enhance the public health system for betterment of all those concerned. In her appreciation, the concerned FDA official, then shared his direct contact and assured her his support for her submissions in future.

mdi’ team is not surprised by Susan’s diligence in her efforts to deal with Agency to correct a problem. She has working on regulatory issues and FDA concerns in her over 26 years of regulatory consulting. Prior to that Ms Goldstein-Falk, was a former US FDA official.

It was good to know that FDA appreciated her for her efforts as well.