MDD_QNA
Involved In Discussions
I've started at a new company and just recently found out that nothing has been done correctly here. What surprises me is how they get to continue with the work they are doing... Anyways, they are developing the product and want to file a 510(k) for one product family and then another 510(k) for another product. However, despite significant changes to the products they have not filed any 510(k)s since 2011 since they have just ignored the regulatory part and/or hired people that couldn't withstand the pressure from higher management.
Anyways, so filing this 510(k) I have told them that we need to report the changes done since the last predicate device. What are your take on this and how should I go about it? What do I tell FDA about them not reporting anything between 2011-2019? Is there another way?
The product is a class IIb medical device with software.
Anyways, so filing this 510(k) I have told them that we need to report the changes done since the last predicate device. What are your take on this and how should I go about it? What do I tell FDA about them not reporting anything between 2011-2019? Is there another way?
The product is a class IIb medical device with software.