In addition to regulation and statutes, FDA CDRH also utilizes standards and guidance to control the development of medical devices. Some of the groups that CDRH relies on include American National Standards Institute (ANSI), Institute of Electrical and Electronic Engineers (IEEE) and Underwriters Laboratories. A searchable database of standards utilized by CDRH can be found at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
Medical devices are regulated by FDA’s Center for Devices and Radiological Health (CDRH). Examples range from simple tongue depressors and bedpans to complex programmable pacemakers with microchip technology and laser surgical devices. They are also subject to premarketing and postmarketing regulatory controls.
Research by Eliza Brannigan & Kristin Peters