Is a completeDevice History Record a must?
This is the same as asking if a teacher needs to complete her entire syllabus for the class. There is considerable debate in the medical devices industry circles about whether some portions of a DHR can be done away with.
Please, please, do not take the DHR for granted. Of course, if inviting a recall is on top of your mind, go ahead and skip any of these steps:
1. The exact date of manufacture of your device, batch, or lot;
2. The precise numbers of the devices you manufactured;
3. Out of these, the actual number that was accepted and taken up for distribution;
4. Most important: All records that show that your support devices are being manufactured as specified in the DMR;
5. Another very important one: Make sure you have included a copy of the ACTUAL product label consisting of carton and/or pouch, along with the product’s Directions for Use;
6. Whatever extracontrol numbers, identification, or serial thatyou may have included.
So, why miss out on any critical information? Just make sure that all these are retained in your DHR. Never ever forget this: You are safe when you document. It is not only your best protection against errors in the process which you can identify at that exact stage and set right at the exact place; it also makes sure FDA cannot catch you by the scruff of your neck. What greater defense to show the FDA than your actual documented records? The FDA is there to check your compliance with QSR, and let us make it easy for them.
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