Due to a lawsuit against Philips Respironics, Federal laws require medical device sellers and manufacturers to comply rigidly with numerous licensing and registration, labeling, and marketing to consumers. Because medical device manufacturers also deal with health care providers whose payment is overseen by programs such as Medicare and Medicaid, government oversight also extends to aspects of the relationship between device manufacturers and health providers. Companies need to review applicable government regulations in each market in which they operate.
Registration Rules
The U.S. Food and Drug Administration (FDA) regulates companies that manufacture, repackage and import medical devices sold in the United States. Manufacturers and first-time distributors must register with the FDA. Manufacturers must also submit documentation for their products. The FDA allows new products to be distributed in the United States only if they have first received a certification of substantial equivalence. After confirming that the product is substantially the same as one sold in the United States, the FDA issues a “commercial distribution approval letter.” The FDA requires applicants to pay fees to have their products evaluated.
Pre-Market Approvals
Pre-market approval is usually required before a product can be used in the United States. This is done because there is no comparable product or poses a potentially high risk of injury or illness. Pre-market approval involves several steps, including the submission of clinical data to support the product’s claims. The FDA may grant an investigational device exemption to test the safety and effectiveness of the device in a clinical trial. Even after approval, device manufacturers are required to report and monitor any potential issues to the FDA.
Advertising and Labeling
The FDA oversees the packaging labels and advertising of medical device manufacturers. At the same time, the Federal Trade Commission oversees all other types of product advertising in the United States. The FDA regulates the advertising of medical devices known as restricted devices. These devices are limited to licensed physicians. The FDA is very vigilant in identifying false or misleading claims in promotional materials. Advertisements for these products must include a brief description of the product’s intended use and associated side effect warnings.
Supplier Relationships
The U.S. Office of Inspector General has monitored relationships between medical device manufacturers and health care providers. This is because the dispensing of medical devices can affect payments to federal programs such as Medicare and Medicaid. Federal anti-kickback laws prohibit types of remuneration from medical device manufacturers to health care providers in exchange for patient referrals. Federal law also prohibits physicians who have a financial relationship with a medical device manufacturer from not referring beneficiaries of federal health care programs to that company.
