Tag Archives: PMA

Reimbursement Report

Humanitarian Use Devices and Third-Party Reimbursement

By Elizabeth Brown, MD
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Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?

Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?

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Recent Pre-Market Activities at FDA

By Sangita Viswanathan
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FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.

FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.

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Reimbursement Report

PMA Approval and Third-Party Reimbursement

By Elizabeth Brown, MD
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The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?

The reality is that often data cannot speak for itself. Even a high-quality randomized study may need the additional support of providers, key opinion leaders and most importantly specialty societies. So what can manufacturers do to address the payers’ stiff evidence requirements?

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