A
Hello all:
My company is preparing a Special 510k to update the FDA on all changes to our product during the past few years since the original 510k clearance.
The question I have is this: during the 30 day clock in which to review a Special 510k, must a company cease sales and distribution until a decision is rendered?
And hypothetically speaking, were the FDA to come back and require a traditional submission (in the instance the Special 510k were not sufficient), would our company be required to cease sales and distribution for that 90 day clock?
Thanks for your help..
Sincerely,
A
My company is preparing a Special 510k to update the FDA on all changes to our product during the past few years since the original 510k clearance.
The question I have is this: during the 30 day clock in which to review a Special 510k, must a company cease sales and distribution until a decision is rendered?
And hypothetically speaking, were the FDA to come back and require a traditional submission (in the instance the Special 510k were not sufficient), would our company be required to cease sales and distribution for that 90 day clock?
Thanks for your help..
Sincerely,
A