FDA Biocompatibility questions for Surgical Gown

[regfocus]

We have a 510k surgical gown under FDA's review.

FDA Questions:

You provided biocompatibility studies; cytotoxicity, intracutaneous, and sensitization for blue gown. You provided information that indicates your gowns will have other colors, like pink, yellow, lavender, and green. Based upon the information provided you did not provide biocompatibility studies for all colored gowns and it is unclear from the test article description. Please provide study protocols and complete biocompatibility studies for your proposed devices that are the subject of this submission.

My questions: Do we need to do biocompatibility tests of each color? Is there any strategies we can use to avoid tests for each color?

 

[MIREGMGR]

Do we need to do biocompatibility tests of each color?

Yes.

Is there any strategies we can use to avoid tests for each color?

Not unless you can convince your examiner that you already have data for the same materials in the same colors from the same vendor(s), for a sufficiently similar application.