“Accessories for medical devices are articles, substances and preparations made from substances which do not in themselves constitute medical devices according to number 1, but are intended by the manufacturer to be used in combination with a medical device so as to enable the latter to be used for its intended purpose as specified by the manufacturer."
Center for Devices and Radiological Health. (n.d.). Medical device accessories. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/classify-your-medical-device/medical-device-accessories#1.
https://www.fda.gov/medical-devices/classify-your-medical-device/medical-device-accessories#1
Institut, J. (2020, October 8). Accessories for medical devices. Johner Institut GmbH. https://johner-institute.com/articles/regulatory-affairs/and-more/accessories-for-medical-devices/.
https://johner-institute.com/articles/regulatory-affairs/and-more/accessories-for-medical-devices/
