“New Normal” for Conducting Business Post-Pandemic at CDRH

CDRH is accepting and holding in-person meetings with stakeholders and also offering hybrid in-person and virtual – meeting options, Director Jeff Shuren said in a statement updating the industry on its return to post-COVID normalcy.

Shuren and CDRH Office of Product Evaluation and Quality Director William Maisel also stated that the Device Center has been “operating under normal review timelines for all incoming premarket submissions for almost a year.”

The authors explained that the center is seeing a resurgence in device innovation having received more submissions for novel devices over the past twelve months than during any 12-month period since the FDA began tracking in 2015.

Read the full announcement here.

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