Wednesday, December 23, 2009

FDA to Revise Rules on Medical Devices

The Wall Street Journal reports that a physician at Northwestern University is being accused of having experimented on humans after he implanted his invention, a Myxo ring, in over 150 patients to stop leaking heart valves without FDA approval. Edwards Lifesciences Corp., which manufactured the rings, decided not to seek approval because it determined the ring was sufficiently similar to approved rings. The dispute is said to have caused the FDA to review its current guidelines over whether medical devices require regulatory approval. Now, according to Bram Zuckerman, director of the FDA's Division of Cardiovascular Devices, the agency may issue revised guidance requiring manufactures to notify the FDA of any alterations to approved products.

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