11 August 2020
In the Federal Register of 20 May 2010, the FDA announced the availability of a draft guidance with the title "Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program; Availability". The idea is to voluntarily place the audit results leading to certification according to ISO 13485 at FDA's disposal. The idea behind it is that the FDA evaluates the inspection results with regard to the manufactured medical devices and the observed deficiencies. Only firms without "major deficiencies or observations" would be accepted. It is the aim to strike the firms with only minor deficiencies from FDA's working plan for a year with the help of a risk-based approach. This shall also contribute to reducing the inspection efforts on the part of the FDA.
At the turn of the millennium, the FDA had already launched the pilot phase of a similar inspection evaluation programme at pharmaceutical companies. At that time, the idea was to gain insight into self-inspection reports and to subsequently determine inspection frequency and depth on the basis of their results. It seems the pilot phase has never been concluded…
On balance, one could say that this concept is an interesting approach, since in general only firms with minor deficiencies can take part in the programme. In this respect, firms with deviations do not have to disclose them to the FDA, as they would not be chosen for the programme in the first place. And to be "spared" an FDA inspection as a reward for a sound QM system might be an additional "carrot" for the trouble of establishing and running a suitable system.
The draft can still be commented until July/August. The corresponding text passage in the Federal Register can be found here.
On behalf of the European Compliance Academy (ECA)