O
orangeisenergy
Hi all,
We are updating an instructions for use pamphlet that goes out with one of our IVD tests. The revision is in response to published findings on acceptable sample collection methods- there are more than the 1 currently defined sample collection apparatus' that will work for our test, so we are adding those to our instructions for use. We will be notifying all customers of the update. My question is: does this change require regulatory notification?
We are updating an instructions for use pamphlet that goes out with one of our IVD tests. The revision is in response to published findings on acceptable sample collection methods- there are more than the 1 currently defined sample collection apparatus' that will work for our test, so we are adding those to our instructions for use. We will be notifying all customers of the update. My question is: does this change require regulatory notification?