Tripartite Biocompatibility Testing Guidelines

The safety and biocompatibility of the dmg delivery system and its components have been extensively tested according to Tripartite Biocompatibility Testing Guidelines (Center for Devices and Radiological Health, 1993). Specifically, these studies have shown that PLA is nontoxic and the hazard potential of NMP is insignificant. Additional preclinical tests to evaluate tissue irritation potential, implantation effects, and biodegradation have been completed for formulations prepared with PLA, PLG, and PLC polymers dissolved in NMP or DMSO. The pharmacokinetics of these formulations have also been tested for specific dmg delivery applications. 

Center for Devices and Radiological Health, 1993, Tripartite biocompatibility testing guidelines, Division of Small Manufacturers Assistance, Food and Drug Administration, Washington, D.C. 

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