Have you had the experience of guiding a new product through concept, development, and final design, and, while you are preparing the product for US introduction, you suddenly stop dead. It seems FDA has decided your product is a medical device!
The basic definition of a medical device is extremely broad, including "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease..." If the product's intended us has some relationship to health, and the product is not a drug, it's possible to define it as Medical Device.
Why should you attend:
Fortunately for publishers, medical textbooks and medical journals have not yet been considered to be medical devices. What has been determined to be medical devices by FDA are laboratory developed tests, and stand-alone software that keeps track of patients condition, that is, LIMS and Electronic Health Records. If you are developing, or considering developing, or considering financing development, you need to have some basic understanding of US medical device law, and this 1.5 day session is designed to give you that.