COVID-19-Era Flexibilities for Imaging, Remote Monitoring Should Stick, AdvaMed Says

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ARTICLE SUMMARY:

As FDA prepares to transition away from emergency-era enforcement discretions and authorizations, the device industry trade group points to three specific COVID-19 device policies that should outlast the pandemic.

FDA is preparing to retire the 17 guidance documents that grant regulatory flexibility to targeted device types for the duration of the federal COVID-19 public health emergency (PHE). But industry wants the agency to make three of the emergency-era enforcement discretion guidances permanent.

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