In This Section
Medical Devices Compliance 2016 in USA
Location:
To Be AnnouncedSan Diego, CA
Event Details:
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.
Host:
NetZealous DBA as GlobalCompliancePanel
For More Information:
John Robinson
support@globalcompliancepanel.com