Definitions[edit | edit source]
General[edit | edit source]
A device is
|“||[a] physical construct, generally electronic, that is capable of storing and processing information, e.g., a Personal Computer, web server, mobile phone, or smart card.||”|
|“||[a] physical entity embedded inside, or attached to, another physical entity in its vicinity, with capabilities to convey digital information from or to that physical entity.||”|
IoT[edit | edit source]
|“||a piece of equipment with the mandatory capabilities of communication and the optional capabilities of sensing, actuation, data capture, data storage and data processing. The devices collect various kinds of information and provide it to the information and communication networks for further processing. Some devices also execute operations based on information received from the information and communication networks."||”|
Medical[edit | edit source]
A device is
|“||[an] 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, in man . . . or intended to affect the structure or any function of the body of man. . . .||”|
Security[edit | edit source]
A device is
|“||[i]n automated assessment, a type of assessment object that is either an IP addressable (or equivalent) component of a network or a removable component that is of security significance.||”|
Overview[edit | edit source]
Devices continue to grow in number and variety as more computers, phones and other machines connect to the Internet. New devices have repeatedly revolutionized the personal computer (PC) market in the past three decades.
Broadband devices[edit | edit source]
When one examines the three main types of devices that connect to broadband service provider networks — mobile devices, computing devices and set-top boxes — one finds that there are many mobile and computing device manufacturers offering hundreds of devices with a dizzying assortment of brands, features and price levels. Whole new device classes, such as tablets, e-book readers and netbooks continue to emerge, shifting firms’ market positions and enabling entrants to capture market share.
Medical devices[edit | edit source]
"[S]oftware applications that runon a desktop computer, laptop computer, remotely on a website or "cloud," or on a handheld computer may be subject to device regulation if they are intended for use in the diagnosis or the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. The level of regulatory control necessary to assure safety and effectiveness varies based upon the risk the device presents to public health."
References[edit | edit source]
- National Strategy for Trusted Identities in Cyberspace, at 32.
- Framework for Cyber-Physical Systems, at 8-9.
- NIST Special Publication 800-152, at 128.
- Overview of the Internet of Things, at 3.
- Food, Drug & Cosmetics Act §201(h).
- NISTIR 8011, Vol. 1, at B-4.
- Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff, at 7 n.4.