QUOTED. 11 June 2021. Vipul Sheth.
The US FDA established the voluntary Remote Regulatory Assessment (RRA) program earlier this year to help it ascertain a device maker’s general compliance with agency rules and expectations. See what Becton Dickinson’s VP of quality and regulatory compliance Vipul Sheth said about the process here.
“Once we have more experience, I think we’ll understand better our decision-making around remote regulatory assessments." – Vipul Sheth, VP of quality and regulatory compliance, Becton Dickinson
- Find out more: To RRA, Or Not RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments
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