Company A manufacures Class 2 and Class 3 implantable devices. It adds a brand new contract sterilization sites for its 510k cleared and PMA approved products. For PMA, FDA requires filing FDA 180 day supplement. What regulatory action for the Class 2 product FDA is required?
FDA guidance docments for 510k changes and the FDA recent guidance documents for the Manufacturer Site Changes provides nothing clear on this. There will be no changes to the sterilization method compared to what was reported originally to FDA.
Thanks for your input
FDA guidance docments for 510k changes and the FDA recent guidance documents for the Manufacturer Site Changes provides nothing clear on this. There will be no changes to the sterilization method compared to what was reported originally to FDA.
Thanks for your input
