QUOTED. 4 June 2021. Korina Akhondzadeh.
Executive Summary
A manufacturer approached by the US FDA to participate in its voluntary Remote Regulatory Assessment program quickly discovered it bit off more than it could chew. Consultant Korina Akhondzadeh of Carlsbad, CA-based KARA & Associates told Medtech Insight the hair-raising tale.
“Once you share your underwear with the FDA, it's going to be kind of hard to say, ‘I don't want you to see my underwear anymore.’” – Korina Akhondzadeh, consultant, KARA & Associates
- Find out more: ‘We Were A Victim’: How An FDA Remote Regulatory Assessment Took One Device Maker By Surprise
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