‘We Were A Victim’: How An FDA Remote Regulatory Assessment Took One Device Maker By Surprise

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. It also didn’t help that the investigator running the firm’s RRA seemed to skirt agency protocol around the assessments. RRAs have taken the place of on-site facility inspections during the COVID-19 pandemic.

An Orb spider squirts venom and traps a ladybird enwrapping its victim in silk threads.
• Source: Alamy

[Editor’s note:To ensure its privacy, Medtech Insight will not name the manufacturer that’s the subject of this story.]

Consultant Korina Akhondzadeh was enjoying a quiet March vacation when she was interrupted by a frantic phone call from a...

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