Design Review is now for real!
Well, it may be hard to believe but it has been a year since the FDA issued the revised
GMP (now called the QSR) regulations. Though there had been a small sampling of companies
that had the "GOOD FORTUNE" to have been inspected in the past year the real
test of these new regulations will now be seen, especially as they will relate to the
Design Control.
This should be an interesting exercise. What I have seen in the past year, luckily to
being present during FDA inspections of several companies, this design review regulations
is going to be like opening a can of worms for the FDA.
It is interesting that the best design review inspections I have witnessed were
conducted during Foreign inspections. This would actually make some sense since Foreign
inspections are conducted usually by the more experienced FDA investigators who would have
a better understanding of the regulations. Also, during the inspection of foreign
companies the FDA investigator tends to use a more understanding and training approach to
their inspections.
The FDA inspections of domestic firms are going to cause havoc for the companies and
complete confusion for the investigators who for the most part and not familiar with these
regulations, how they are to be audited and enforced. We will have to wait and see the
FDA's compliance policy guide on the inspection of companies using these new regulations.
In the meantime, how does a company prepare for this Design Review inspection? This is
an interesting question if you are a small medical device manufacturer and don't have an
engineering staff. The best advise I could give at this time, without know how the FDA
intends to enforce the Design Control section of the QSR is to attempt to document to the
best of your ability all your design operations.
In any case, you will be required to have a Design Control procedure that should
address all aspects of the regulations so that the FDA investigator could review it, in
the event you did not actually perform any design reviews.
As soon as I obtain a copy of the updated FDA's Compliance Policy for inspecting
medical device manufacturers, I will provide you some guidance on how to conduct design
control and what the expected consequences would be if you are found not complying with
this newly enforced regulation.
If you have experienced a design control inspection by the FDA and want to tell others
how it went, please let me know and I will post it on this site.
NEXT MONTH - "The CE mark and the US Medical Device Industry"
