Device Registration and Listing - Separate for Device and corresponding Instruments?

[JDV1428]

I am currently updating our facilities Device Registration and Listing for a recently approved Class II device. I have updated the device listing for the implant. All instruments we supply with it are the same classification as the implant. My question is, do all off the corresponding "Class II" instruments that are specific to that implant fall under the implant device listing. I don't see where there are seperate device listings product codes for instruments unless of course they are Class I expempt. I have searched the FDA sight and have followed their instructions to update the device listing but am wondering if I missing something? Any help, or pointers toward references regarding updating device listings would greatly help this regulatory novice.

 

[Totumfrog]

Re: Device Registration and Listing - Separate for Device and corresponding Instrumen

I just completed listing dozens of class 1 and class 2 devices or implants due to the recent changes in definition of a contract manufacturer. During my time on the FDA FURLS website I only saw "parent" type product codes that one would then list either Class 1 or Class 2 devices or implants as "children". If the Class 2 device has a product code and "All instrument...you...supply with it are the same classification as the implant" then I believe they would all fall under the same product code thus the same listing. I have added notes to my class 1 or class 2 devices. You could add "instrument" or "implant" to each listing you place under each product code. I recommend the privacy setting as well. I marked everything confidential. Hope this helps.