I hope that you are all aware that the FDA’s revised GMP the QSR is now if full force, except for the Design Review which will go into effect in June. But, if you have not had an FDA inspection since June, the next FDA inspection may hold some surprises for you.

In several recent FDA inspections that mdi staff assisted our clients with, the FDA investigators conducted their inspection with the usual intensity, but there was one area that was new to their inspectional policy. The investigators during their inspections of electrical devices asked for and performed an extensive review of the cleared 510(k) application for the devices being inspected. This request may not have been out of the ordinary if they were just looking for changes to the original 510(k), which the FDA has been doing for several years now. But, the investigators were reviewing all the specifications as listed in the device manuals or labeling and would request the tests results to support the claims. For example, if you stated as a specification 95% humidity, they would want a copy of the testing showing that the device would perform at this humidity.

If you have a copy of these test results then you would have any problem. But, if these tests were not performed, and usually they may not have been performed because the FDA’s Office of Device Evaluation may not have requested all the tests, the FDA investigators are reporting this observation on the FDA 483.