J
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.