Heated Public Meeting Illustrates Vexing FDA/CMS Tussle to Regulate IVDMIAs

During a public meeting convened by the FDA, most of the 30-plus presenters said the agency’s draft guidance to regulate IVDMIAs, in its current form, is untenable, even potentially illegal. A minority supported the document and said the agency should play a role in ensuring patient safety and device efficacy.

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