In a MedTech Dive article republished in Yahoo Finance, life sciences regulatory & compliance counsel Beth Weinman discussed the “incredible undertaking” that Philips will have to undergo to meet requirements in the Food and Drug Administration consent decree that bars Philips from selling certain sleep and respiratory products in the U.S. until it proves compliance.
Beth said the consent decree and invocation of a rarely used authority to require the repair, replacement or refund of devices reflects “a significant lack of trust.”
“FDA wants companies to do what they need to do and voluntarily come into compliance. I don’t think the agency relishes having to do the work to come up with a plan and a consent decree like this,” said Beth.
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