RIMSYS’ own James Gianoutsos recently contributed an article on www.meddeviceonline.com 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.

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