FDA updates premarket review appeals and deficiency letters guidances

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has updated guidance documents covering appeals processes and procedures for medical device premarket review decisions, as well as for developing requests for additional information for FDA registrants whose applications are deemed deficient.

Get the full story here at the Emergo Group’s blog.

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