Medical Devices
Medical devices are regulated by the U.S. Food & Drug Administration’s Center for Devices and Radiological Health (CDRH). Examples of medical devices range from tongue depressors, to bedpans, to complex programmable pacemakers with microchip technology, to laser surgical devices. These medical devices are subject to pre-marketing and post-marketing regulatory controls.[1] [2]
The CDRH uses standards and guidance to control the development of medical devices. Some of the groups that CDRH relies on include the American National Standards Institute (ANSI), the Institute of Electrical and Electronic Engineers (IEEE), and Underwriters Laboratories. A database of standards used by the CDRH can be found here.
The CDRH Standards Program contributes to the mission of the CDRH, which focuses on protecting and promoting public health through the development and recognition of standards that aim to establish safe and effective medical devices. The CDRH Standards Program is a leader in terms of standards implementation and use for medical device innovation and manufacturing, as well as radiation-emitting product safety.[3]
Comments are closed.