The FDA has a lot more to say about the operations of a laboratory than most lab owners realize. From regulating the materials and some equipment that labs use to requiring implementation of a Quality System and Good Manufacturing Practices, Gary Morgan, CDT, discusses how the FDA is a part of your business. Registration with FDA may be required for certain activities from manufacturing sleep appliances to customized implant abutments. This presentation covers everything you should know about FDA and your lab, including the 510(k) process.