Is the Fluoro-Seal Process FDA compliant?
A. Yes. The Fluoro-Seal Process complies with FDA regulations in accordance with 21CFR Ch. I, Pt. 177.1615 a, b, and c. Note: The DOT lists a general procedure for testing chemical compatibility and rate of permeation. This may be helpful for your evaluations and may be found at: Appendix B.49 CFR Ch. I, Pt. 173, Appendix B. Please have your FDA affairs group locate the most recent edition of the CFR and provide you with advice and guidelines in adhering to any and all regulations that may apply to your particular application.
