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CryoLife submits corrective plan to FDA:

This article was originally published in Clinica

Executive Summary

CryoLife has submitted its corrective action plan to the US FDA outlining proposed steps to validate the company's tissue processing procedures. It is currently processing tissue for use in medically urgent cases under the terms of a 45-working-day interim agreement signed on September 6 with the FDA, which also stipulated that the company draw up the action plan in collaboration with a third-party consultant or reviewer within 30 days. The agency will now decide whether to allow CryoLife to return to the market and release tissue subject to the original recall order of August 13 (see Clinica No 1027, p 17). The company's share price closed up 25% at $2.69.

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