In Reply to Parent Post by ryno fan
1. My understanding of FDA's requirements for Device Listing for medical device manufacturers is to list all Class II and higher devices on FURLS (FDA's Unified Registration and Listing) system; and at least 1 representative Class I device from each device family (classification number and product code). Is this accurate?
2. Is there a requirement for manufacturers to list their marketed medical device accessories?
I agree with the comments above on question 2, but an additional comment: the key question regarding an "accessory" is not what you call it or whether you market it as an accessory or a device. It's whether it objectively meets the definition of a device. If it does, then it's a device and has to be listed.
As pointed out, some products that do not meet the definition of a device nonetheless have to be listed because there is a specific ProCode for that accessory type.
On question 1, the answer depends on your definition of "product family".
If for instance you make 500 minor dimensional and feature-detail variants of a camera drape, you could internally document that all of those products belong to your "camera drape" family. You would have a single listing for "camera drape". The key consideration is that all the product family members have the same ProCode.
You however could not group together several towel drapes, camera drapes, microscope drapes, slush machine drapes, etc. and call them a single product family, because they have various ProCodes.
There is no distinction between Class 1 and Class 2 regarding "product families". If you offer several minor variants of a product, all having the same basic description and intended use and the same ProCode, they can be a product family.