QUOTED. April 5, 2018. Sean Boyd.
Check out what FDA device compliance officer Sean Boyd had to say about the prospects of applying least-burdensome requirements to inspections and warning-letter close-outs.
"In the case of inspectional interactions, least burdensome approaches could streamline the way we interact and follow-up to an inspection, or when we’re requesting additional information from industry to evaluate and ensure that those findings are remedied, which could impact, for example, warning letter close-outs." – Sean Boyd, deputy director for regulatory affairs, CDRH's Office of Compliance
- Find out more: FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack
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