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Bringing Private Payers To The Regulatory Table: FDA Reaches Out To Insurers

The agency's device center put out a request to health insurers to make themselves available to participate in FDA pre-submission meetings so that device firms, particularly start-ups, can better understand data expectations for coverage while companies are still designing studies to support FDA approval.

FDA wants more device companies to consider inviting payers in the room during FDA pre-submission meetings. To accomplish this goal, the device center is taking steps to serve as a matchmaker of sorts between product developers and private health insurers to facilitate earlier conversations about what data will be needed to support positive coverage policies.

The agency put out a notice on Feb. 23 asking for buy-in from private payers. It is a...

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