Word of the Day: medical device class (MDC)

Word of the Day Daily updates on the latest technology terms |July 13, 2017

medical device class (MDC) Medical device class (MDC) is a regulatory category defined by the United States Food and Drug Administration (FDA). In the United States, the FDA has the authority to regulate medical devices before and after they reach the marketplace. A medical device's class determines what controls have been put in place to manage risk and assure patients, doctors and manufacturers that the device will operate safely and effectively. Class I includes devices with the lowest risk and Class III includes those with the greatest risk. Class I Medical Devices - devices in this class have a simple design and pose little to no potential risk of injury or illness to patients or operators. Examples of devices in this category include oxygen masks, examination gloves and tongue depressors. Class II Medical Devices - devices in this class have a more complex design and pose minimal risk of injury or illness to patients or operators. Examples of devices in this category include wheel chairs, X-ray machines and cardiac monitors. Class III Medical Devices - devices in this class have an intricate design and support or sustain human lives. Devices in this category are capable of posing substantial risk of injury. Examples of devices in this category include heart valves, implanted pacemakers and cerebral simulators. The FDA requires Class III devices to be designed with a balance between ease-of-access and strong cybersecurity controls. Quote of the Day "The FDA medical device guidance has many good recommendations on how enterprises should treat medical devices with IT components as an important part of their IT infrastructure." - Nick Lewis   Trending Terms FDA telepresence robot Reference Information Model HIPAA medical body area network remote patient monitoring   Learning Center Medical device safety needs to be given more attention, an expert says Rather than focus on medical device safety, healthcare agencies have focused on patient privacy, one expert said. Applying the new FDA medical device guidance to infosec programs The new FDA medical device guidance for manufacturers should be incorporated into enterprise infosec programs, too. Learn about the important takeaways. Connected medical device security: The usefulness of unenforceable guidance If manufacturers and healthcare systems can together tackle the connected medical device security challenge, it will create a safer environment for patients. Cybersecurity of medical devices: The new threat landscape Cybersecurity of medical devices is even more important during a time of constant attacks. Experts discuss precautions to take and the FDA's guidance. How technology can improve medical device safety in infusion pumps Medical device safety in the connected infusion pump arena requires better software to manage accuracy, intelligence and usability of the pumps. Writing for Business The FDA reclassified sutures as Class II medical devices in the early ______. A. 1990's B. 1990s Answer       Stay In Touch For feedback about any of our definitions or to suggest a new definition, please contact me at: mrouse@techtarget.com   Visit the Word of the Day Archives and catch up on what you've missed!   FOLLOW US About This E-Newsletter This e-newsletter is published by the TechTarget network. To unsubscribe from Whatis.com, click here. Please note, this will not affect any other subscriptions you have signed up for. TechTarget, Whatis, 275 Grove Street, Newton, MA 02466. Contact: webmaster@techtarget.com Copyright 2016 TechTarget. All rights reserved.