Accessory Device Medical

Medical Device Accessories | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/medical-device-accessories

What is a medical device accessory? An accessory is a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. A parent...

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways

FDA developed this document to provide guidance to industry and FDA staff about the regulation of accessories to medical devices. This guidance is intended to …

Think Your Accessory Isn’t A Medical Device Think …

https://www.meddeviceonline.com/doc/think-your-accessory-isn-t-a-medical-device-think-again-0001

If there was any confusion as to whether a specific accessory is classified as a medical device, it has now been clarified, or at least partially clarified, …

Accessories for Medical Devices - Johner Institute

https://www.johner-institute.com/articles/regulatory-affairs/and-more/accessories-for-medical-devices/

“Accessories for medical devices are articles, substances and preparations made from substances which do not in themselves constitute medical devices according to …