An overview of FDA regulatory requirements for new medical devices.

Background: US national healthcare expenditure reached over 2 trillion dollars in 2007. medical device expenditure has remained nearly a constant 6% of the total healthcare expenditure. medical technology may be one of the driving factors increasing healthcare costs. the number of medical device (which includes diagnostic tests) and laboratory equipment manufacturers, and investment in research for medical devices continue to rise. medical device manufacturers can receive a higher than average return on investment if they successfully navigate the food and drug administration (FDA) approval process.

Objective: this paper focuses on the series of steps a manufacturer can pursue to facilitate the introduction of a new device to the us market.

Method: a review of the FDA regulations and current literature was conducted.

Results/conclusion: exemption from a full review by the FDA owing to substantial equivalence is one of the pathways a manufacturer can pursue for quicker and easier approval of the new device. three classes of devices are reviewed, as are some of the key regulations governing them. the regulations for advertising and promotion are still unclear because of the gray area that exists between the federal trade commission and the FDA. this paper concludes by summarizing the advertising and promotion regulations set forth by the FDA during the post-approval phase.