by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
The Federal Register notice provides the following definition of a medical device data system: § 880.6310 Medical device data system. — (a) Identification. A medical device data system (MDDS) is a device that is intended to provide one or more of the following...
by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt. Cleared medical devices: These medical devices are ones that FDA has determined to be substantially...
by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
There are various processes that FDA use to review information about medical devices before they are allowed to be marketed in the United States: Premarket Notification [510(k)] – submission required to demonstrate that the device is substantially equivalent to a...
by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
The FDA regulates a wide range of medical devices, including, pacemakers, cardiovascular stents, respiratory ventilators, breast implants, diagnostic tests (pregnancy tests, blood glucose tests, etc.) and relatively simple devices such as tongue depressors, patient...
by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States...
