The FDA serves a vital public service in policing what products are allowed to enter the stream of commerce and be marketed to treat medical conditions. When the FDA rejects an application by a company to market a product for a particular use, the case should be closed without further study and application by the company. Too often, medical device and equipment companies, just like big pharma, plow right through FDA denials and market expensive products determined unsafe for a particular use. This causes fraud on Medicare, Medicaid and other government health programs that should not be paying for false claims on such products and uses. It is encouraging to see more criminal prosecutions in this area, where it is well-deserved. — Shayne Stevenson, Head of Whistleblower Practice