Hello All,
My company makes convenience kits that include class I and class II devices. I am new to this role and finding that things may have been done incorrectly. I am having trouble finding the correct answers. I have read the guidance documents and still find myself with many questions.
for GUDID:
The kits are called kits, yet "KIT" is not checked off the class II device information is listed and the GMDN is for the class II device. Now that we will be moving to requiring the class I devices to be listed, how will this work? Should the kit have its own GMDN?
for Registration:
if so, should the kit be registered as a kit separately?
thank you for your assistance.
Regards,
~Auditgirl
My company makes convenience kits that include class I and class II devices. I am new to this role and finding that things may have been done incorrectly. I am having trouble finding the correct answers. I have read the guidance documents and still find myself with many questions.
for GUDID:
The kits are called kits, yet "KIT" is not checked off the class II device information is listed and the GMDN is for the class II device. Now that we will be moving to requiring the class I devices to be listed, how will this work? Should the kit have its own GMDN?
for Registration:
if so, should the kit be registered as a kit separately?
thank you for your assistance.
Regards,
~Auditgirl
