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This fact has emboldened many to believe that the FDA will not take any action to remove Regenexx from the market despite its observations in 2008 that Regenexx appeared to violate the existing FDA regulatory framework.
Frequently Asked Questions Chris Centeno 2015-04-27T07:58:10+00:00. The Regenexx procedures performed in the United States are compliant with CFR 21 Part 1271 and fall under the same surgery exemption discussed in 1271.15 (b). Click the toggle above for full details.