FDA Modifies List of Recognized Premarket Review Standards

October 25, 2019

The FDA has published changes to its list of recognized standards for premarket reviews of medical devices.

The changes to consensus standards, which have been posted in the Federal Register, are also viewable online on the agency’s recognized consensus standards database.

The modified standards are for anesthesiology, cardiovascular, dental, nose and throat, and in vitro diagnostics devices, among others.

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