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MDMA (Medical Device Manufacturers Association) takes FDA to task over patient safety on SUDs (single use medical devices) issue

The Medical Device Manufacturers Association (MDMA) has accused the US FDA of failing to take appropriate steps to protect patient safety with its regulatory scheme for reused single use medical devices (SUDs).

The Medical Device Manufacturers Association (MDMA) has accused the US FDA of failing to take appropriate steps to protect patient safety with its regulatory scheme for reused single use medical devices (SUDs).

A key concern, the trade group's executive director Stephen Northrup said, is that reprocessed single use devices are subject to pre-market submission requirements based on their original device classification of:...

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