Is a medical device accessory a medical device?

Medical Device Accessory



Rimsys’ own James Gianoutsos recently contributed an article on discussing FDA’s guidance document describing accessories and classification pathways.


The guidance explains which devices FDA generally considers “accessories” and describes the processes under Section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow requests for risk- and regulatory control-based classification of accessories. In other words, it specifically details what is and is not an accessory, as well as the regulatory routes to classification.

Rimsys is a world-leading provider of Regulatory Information Management (RIM) software designed specifically for the medical device industry. Rimsys offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, UDI requirements, regulatory documents, changing regulations and more.