To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments
Three Becton Dickinson facilities have been approached by the US agency to take part in the voluntary virtual assessments; the medtech giant declined one and accepted two. BD’s VP of quality and regulatory compliance explains why.
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IVDs: ‘Every Non-COVID Premarket Submission That Was Held Up Is Moving Forward’ Soon, FDA’s Shuren Vows
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Medtech quality expert Rob Becker says the COVID-19 pandemic has likely changed the structure of audits and inspections forever, possibly ending the use of on-site “front rooms” where inspectors would work and “back rooms” where company employees would fulfill requests for documents and other items.