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Better Reimbursement, More Incentives Needed For Peds Device Development, Stakeholders Tell FDA

At a recent pediatric medical devices workshop at US FDA headquarters, the focus turned less to regulatory burdens and more to lacking reimbursement and financial incentives as barriers to bringing child-focused products to market.

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Industry experts at a two-day US FDA workshop say financial assurances, including reimbursement guarantees, will go a long way to encourage developing medical devices for children. Among the suggestions made by stakeholders and experts at the meeting was to provide more funding through Pediatric Medical Devices Consortia grants, legislative efforts to change the reimbursement landscape and potentially new philanthropic investment models.

When Congress passed the Food and Drug Administration Reauthorization Act of 2017, the agency was told to work with stakeholders...

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