Has your dental lab ever had the pleasure of being inspected by FDA according to 21 CFR: 820? If you have to ask what 21 CFR part 820 is, then you probably haven’t.
21 CFR:820 (known as the QSR or Quality System Regulation) includes the requirements related to the methods used in and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use – including those for dental use.
What is an FDA Inspection and How to Navigate It
There are four types of FDA inspections. They are: Pre-Approval, Routine, Compliance Follow-up and “For Cause”. There are many sources available on the web for information on these, but for the sake of most dental laboratories we’ll just address Routine.
By Federal law, the FDA is required to perform routine inspections on every Class II or Class III medical device manufacturer every two years, but it is widely known (as well as addressed by FDA) that doesn’t occur because of the sheer number of manufacturers and the resources available to FDA to perform the inspections. Google FDA’s website for QSIT (Quality System Inspection Technique) and one will find it was published in 1999, but is still the tool used by FDA’s quality inspectors.
If your facility is involved in the manufacturing of a Class II or Class III dental device, then you have the potential to be inspected by the FDA. If the FDA comes for an inspection, ask to see their credentials if they aren’t offered automatically. After verification, have a pre-planned area where the inspector will sit and perform their work. FDA usually asks members of management to sign a pre-printed affidavit, but all FDA consultants advise their clients to politely refuse. The inspector will want to identify the most senior members of management, especially the Head of Quality and most often will want to talk to them. This person will serve as a guide to point the investigator in the correct direction related to the questions the inspector has.
Usually the first directive inspectors check is a documented Quality Management System (QMS), complete with procedures and work instructions. They will ask if the facility has identified a Management Representative, has a documented Quality System, and when was the date of the latest Management Review. The answer to these three questions tell the investigators a lot about your Quality System. Next, the inspectors will ask to see the Quality Manual, hard copy or electronic, and will verify the existence of your quality procedures, work instructions, etc. Inspectors usually want to see proof of, not the actual data, of performed quality system audits. These are internal audits the facility has performed either by the employees or contracted consultants.
Labs that have had an FDA inspection all have one thing in common. They wish that they had been more prepared. It isn’t possible to address every possible thing that might be covered in a visit, but the better you are prepared, the easier and quicker the experience will be for you.