Surprise – Chief Jailable Officers Get Put in Jail
The only takeaway the doctor is going to leave with the readers for this edition of DG is eloquent in its simplicity; “always do the right thing!”
Tag Archives: Devine Guidance
Buyers Beware!
What happens when the contract manufacturer a device establishment selects for manufacturing support runs afoul of FDA?
Who Wants Clean Air and Water?
The QSR does not dictate how to execute a Receiving Inspection program; it only stipulates that purchased materials must be assessed for their suitability to be used in the manufacture of medical devices that are safe and effective in their intended use. It is up to the establishment to define their approach to RI.
Design Changes Often Require FDA Scrutiny!
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.
Manufacturers of Class I and Class II Exempt Devices Still Require a QMS
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.
The Training Tradeoff – Trained Employees that Leave versus Untrained Employees that Remain
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?
Surprise – We Are Here For an Unannounced Audit!
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.
What does Adulterated Mean?
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.
Maybe 13 is an Unlucky Number
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.
No Written Procedures, Seriously?
Script written procedures and actually use the procedures to run your organizations. Without written procedures, there is nothing but chaos.
