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On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions

US Regulatory Roundup, November 2020

 
• By Shawn M. Schmitt

A sharp decline in the number of in-person facility inspections has forced the FDA to consider creative techniques for remotely evaluating manufacturer compliance during the COVID-19 pandemic. This and other stories topped our list of most-read Medtech Insight articles in November.

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The number of on-site inspections of medical device facilities performed by the US Food and Drug Administration between mid-July and mid-November fell by an eye-popping 93% from the same time frame last year. That’s forced the agency to consider creative techniques, including records requests and the use of video, for remotely evaluating manufacturer compliance during the COVID-19 pandemic.

The FDA told Medtech Insight it conducted a mere 35 domestic in-person inspections from 20 July – when the agency began inspecting again following a four-month break due to the...

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