Significant changes made to the design or processing of finished medical devices, that are safe and effective in their intended use, require the review and subsequent approval of FDA. This includes changes in the indication for use.
It is incumbent upon your organizations to ensure that the classifications of devices entered into commerce are properly classified and the applicable QMS requirements understood and implemented. Class I or Class II exempt has nothing to do with the actual QSR requirements and pertains only to the regulatory pathway.
One concern we frequently hear is absorbing the expense associated with training and then key employees departing the organization for greener pastures after their training has been completed. But what about the costs associated with mistakes and errors employees make, when employees are not properly trained and decide to stick around?
Unannounced notified body audits are nothing new. Unfortunately, because of one really bad apple in the industry and a perception of the regulatory environment in the EU lacking teeth, the Commission has come up with an unrealistic and expensive solution for industry.
A surprise visit from FDA and a non-compliant QMS will likely result in devices being identified as adulterated. Entering adulterated devices into commerce in the United States may result in a warning letter.
In the United States, to manufacture and/or enter devices into commerce, device establishments are expected to have written procedures that are fully implemented and in compliance with the QSR and subsidiary regulations. Do not be that organization that receives 13 Form 483 observations because procedures have not been established.
Script written procedures and actually use the procedures to run your organizations. Without written procedures, there is nothing but chaos.
Production and process control is not a difficult section of the QSR to comply with. However, it does take some work scripting procedures that delineate the production process.
Management responsibility is one of the most important requirements delineated in the QSR. If management has no clue as to what is going on in their facility or fails to take appropriate action when serious issues transpire, then just maybe a warning letter isn’t appropriate.
Whenever phrases such as “data falsification” are referenced by FDA in a warning, the offending organization will probably become familiar with the acronym DOJ, as in investigation. Falsifying data that may have resulted in the overall compromising of product safety and efficacy is a serious accusation.
