The MIT Media Lab transcends known boundaries and disciplines by actively promoting a unique, antidisciplinary culture that emboldens unconventional mixing and matching of seemingly disparate research areas. The Lab creates disruptive technologies
that happen at the edges, pioneering such areas as wearable computing, tangible interfaces, and affective computing. Today, faculty members, research staff, and students at the Lab work in 27 research groups on more than 470 projects that range from
digital approaches for treating neurological disorders, to advanced imaging technologies that can “see around a corner,” to the world’s first “smart” powered ankle-foot prosthesis.
Lab researchers are committed to delving into the questions not yet asked, whose answers could radically improve the way people live, learn, express themselves, work, and play. More information athttps://www.media.mit.edu/.
FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III. Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls.
What is a Class 1 medical device?
Bedside Medical Device
Who regulates medical devices in the US?
The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic (FD&C) Act.
Is Your Product Regulated? - Food and Drug Administration
Medical device (brief): An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.
Definition in United States by the Food and Drug Administration. Medical machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory that is: Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them.
Dec 28, 2015 - recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or.