I know we beat around that bush some on another thread but there is a bunch of stuff that goes into becoming FDA compliant.
In a nutshell, here is all you have to do to be FDA compliant, assuming you keep the proper documentation:
1) Carefully scrutinize the companies we choose to do business with, only selecting vendors with a proven track record of producing quality products, providing excellent training and standing behind those products. If it's a new company, or a little company, you are taking chances. There is one company who I have spoken about here who is private labeling zirconia. When I had problems with a product I bought from them, they went into radio silence and quit returning calls or e-mails. Would you stake your reputation and bank account on this kind of company? Do they have FDA registration for the application they are advertising, and do you have all the FDA mandated packaging and markings?
I'm not saying not to do business with little companies, but do your due diligence, ask around, post some questions on Dental Town etc, and inquire about warnings or complaints by the FDA. Pay them a visit.
2) Review your products annually. What is an acceptable remake percentage? How is this product performing in-house and introarally? What is in the scientific (CRA) literature about it? Are the reports from the field favorable? Are you finding that certain types of cases are working better or worse than others? Does your experience contradict the manufacturers indicated uses? Should you keep doing this product?
3) Update your standard operation procedures and manufacturing protocol. Are you following the manufacturers most up-to-date instructions for use? Has anything been changed or updated since you were trained on the product, have they changed any parameters, formulas or materials? Have they added or changed any indications, contraindications? If you were trained by a contracted technician, did he teach you any shortcuts or tricks that disagree with the instructions for use? Did you get any certificates or licensing documentation? Is it properly filed and can it be renewed annually? Even if it's voluntary, do it. You need it if you start having failures.
Be sure every technician who touches a product is trained and documented to do that work, and keep track of everyone who touched a case. Never try out a new technician on a real case, and do not play with new techniques or materials on live cases.
4) Are you calibrated? We all saw the failures reported when zirconia frames were not being fired at the right temperatures and rate of climb. Those were just very minor differences, and they still looked perfect even though they were flawed. How will your products be affected if your equipment is not performing properly, and temperatures are too high or too low, or timing and cycle sequencing are off? If these products fail because of your machinery, whose fault is it? Yours or theirs?
5) Control Inventory. Have a strict process for who has access to materials that might be mishandled, contaminated or expired. Do not mix and match old materials and if new materials are released, resist your hoarding instincts and dispose of them. Have a process for checking that the materials you receive are what you ordered, and that you have a system in place to identify materials in the event of a recall. Only use qualified vendors and do not substitute any restorative constituents. Die stone yes. Opaque, NO.
6) Failures and corrective action The FDA has guidelines of what kind of products need to be reported in the event of a failure, and I have posted that material here before. Regardless of if you need to report failures, you still need to track them. The same thing with complaints or other problems. You also need a process for evaluating and taking corrective action. If you still have failures or if you suspect a product is faulty, you can still report this to the FDA. Maybe you are not alone, and lots of these things are going bad.
Do not be tempted to troubleshoot these problems yourself. If you have impeccable documentation that you are properly certified, and following SOP's to the letter, if your materials are fresh and unadulterated, and your equipment is working properly and is calibrated and maintained, the liability falls back on the manufacturer. But as soon as you start playing mad scientist, all bets are off and you alone hold the bag my friends, and the FDA (and the manufacturers whom you are making look bad) would love to see your little shop of horrors closed down.