FDA regulations – California Transplant Services, Inc.

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[ March 16, 2016 ] Autologous Recordkeeping Q & A FDA regulations
[ January 6, 2016 ] FDA Proposed Guidance for Same Surgical Procedure Exemption FDA regulations

Autologous Recordkeeping Q & A

March 16, 2016 marcpablo 0

We were recently asked by a hospital if they really need to keep the pink copy of the Autologous Tissue Preservation form. The question was: The information form we fill out in the autologous […]

FDA Proposed Guidance for Same Surgical Procedure Exemption

January 6, 2016 marcpablo 0

A DRAFT guidance for industry was published in October 2014 by the FDA for Same Surgical Procedure Exemption. I highlighted the line 171 which establishes the need for hospitals to register with the FDA as […]