The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.
There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.
The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation.
There really is no excuse for receiving a Form 483 observation for management review.
It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.
Money should never be a higher priority than safety and efficacy.
You can’t just validate processes—you have to monitor them, too.
Problems have persisted with the Essure System. What’s FDA’s next move?
FDA simply won’t tolerate extreme claims outside a product’s cleared or approved use.
If you’re using software in the product development process, it better be validated.