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Has anyone had good experiences with particular test labs for microbiology testing as described in the 2005 Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) guidance?
FDA indicates that the product must neither increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) nor alter the growth of normal vaginal microflora, but does not recognize a particular methodology to do so.
For tampon materials, we recommend that you demonstrate that the tampon, in its final manufactured form, does not:
• enhance the growth of Staphylococcus aureus
• increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)
• alter the growth of normal vaginal microflora.
Any insight would be greatly appreciated. Thank you!