Regulation and certification issues.

Regulatory and certification issues for endoscopy are complex, detailed, and broad. The different sources of the myriad regulations often have conflicting agendas, and the venues that seek to regulate endoscopic practice often overlap and seem redundant. Nonetheless, in spite of, or perhaps as a result of stringent regulation, endoscopy in the United States in thriving and continues to grow each year. Moreover, the penalties for not following the various regulations can be severe, and may result in criminal and civil sanctions. Any physician starting or already participating in a freestanding endoscopy center is well served by becoming familiar with the intent and generalities of each regulatory situation, and seeking appropriate legal and consulting counsel for specifics.