A medical device start upis preparing its first product for regulatory submission to the US FDA. The company plans to have the establishment prior commercialization of the product. Is it acceptable to submit under these conditions?

a.No, the entire GMS must be in place prior to the first submission

b.No, the product should have been developed under design control

c.Yes, the FDA only requires GMS to be active at the time of commercialization

d.Yes, provided the latest version of the device was the one verified and validated