I’ll Bet You Didn’t Know…

I recently had an opportunity to visit with the Vice President of Operations at a small medical device start-up in the San Diego area.  He began our visit by taking me immediately on a tour of his new facility.  You could tell—and rightfully so—that he was proud of the work he and his team had accomplished over the past few years.  The facility was clean, well organized, and the firm clearly had room to grow.  The employees I met were courteous and professional in their actions and they appeared to be enjoying the working environment as well as their work.

One thing I noticed during the tour, however, was the absence of the usual business licenses, permits, and certificates one would expect to be posted in a somewhat prominent location for a medical device manufacturer actively commercializing its products.  For example, I would expect to see a business license, a hazardous waste permit (the treatment or disposal of medical waste is considered hazardous), or should you be selling in Europe, a CE mark certificate along with perhaps an ISO 13485 quality management system (QMS) certificate.

When I mentioned this, the Vice President of Operations was quick to tell me that the firm had no plans to commercialize product in Europe and not to worry because he and his Quality Assurance Manager had written a quality management system (QMS) meeting US Food and Drug Administration (FDA) requirements.  I asked if he had ever had the QMS audited by an independent outside auditor.  He replied “no” and not to worry because the facility was registered with the FDA.  I then asked about State of California requirements (see Sherman Food, Drug, and Cosmetic Law).

The Vice President of Operations reply was, again, not to worry because the facility was registered with the US Food and Drug Administration (FDA).  I was beginning to sense a pattern here, so I thought I would take an opportunity to share with him that the State of California Department of Public Health has a Food and Drug Branch (FDB) that is intimately concerned with the manufacture of medical devices, drug products, and cosmetics.  Of course, it is also intimately concerned with the production of food products such as tortillas and the running of chicken farms, but that is perhaps a story for another day.

It is a Food and Drug Branch (FDB) requirement that all medical device manufacturers (as well as drug and cosmetic producers along with others) obtain a state manufacturing license.  The licensing process requires the manufacturer to complete an application (available on the Food and Drug Branch (FDB) website) and pay a fee.  Concurrent with the application, the manufacturer provides one of four pre-determined forms of documentation evidencing QMS compliance or exemption (i.e. FDA biologics license, FDA inspection attestation, ISO audit report, or FDA investigational device exemption).

Before I left, I politely encouraged the Vice President of Operations to visit the Food and Drug Branch (FDB) website to see for himself.  Perhaps it was body language or a tone of voice, but I’m pretty sure he thought I was blowing smoke—you get a feeling when someone is rolling their eyes at you inside their head.  Nevertheless, for those among us open to new ideas, the FDB takes the position that before you distribute a medical device anywhere for clinical use that is manufactured within the state of California whether approved or not, commercialized or not, you are required to obtain a state license.