In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition.

The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) medical device regulator, has announced that it plans to recognize five new standards maintained by ...

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions. Congress broadly directed federal ...

The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as ...

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions ...

The year 2009 is remembered in medtech regulatory circles as the year in which long-simmering turmoil erupted into the open at FDA's Center for Devices and Radiological Health (CDRH). It cost Daniel ...

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