Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File
Lately, it appears that FDA is making efforts (or struggling with) to clarify two grey areas:
(1) Malfunction and the criteria of its reportability;
(2) Threshold that a design change to trigger 510(k) submission
Both areas are sensitive, and a firm could easily be given 483 and Warning Letter, if any violation is detected in FDA inspection.
But, despite the suffering that the industry had, FDA has the most comprehensive and informative database of device adverse events among all regulators. I personally respect FDA's achievements in this, although I dislike FDA.