ARTICLE
30 November 2018

New FDA Draft Guidance On Uncertainty Considerations In Benefit-Risk Determinations For Medical Device Premarket Approvals

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Duane Morris LLP

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FDA provides authorization for marketing a device when its benefits outweigh its risks.
United States Food, Drugs, Healthcare, Life Sciences

The Food and Drug Administration recently issued draft guidance entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions." Comments to this draft guidance should be provided by December 5, 2018.

FDA provides authorization for marketing a device when its benefits outweigh its risks. Uncertainty surrounding these benefits and risks is a factor that FDA considers when making its determination with respect to premarket approval application (PMA) approvals, de novo classifications, 510(k) clearances, humanitarian device exemption (HDE) approvals and investigational device exemption approvals. As it has in previous guidances, FDA attempts to provide "a flexible, patient-centric, benefit-risk approach" that is "tailored to the type and intended use of the device and the type of decision" required. For example, PMA and de novo requests require a demonstration of reasonable assurance of safety and effectiveness. However, HDE applications inherently have a greater uncertainty surrounding the benefit-risk profile as Congress provided that these applications need not show a reasonable assurance of effectiveness as the patient population is generally very small.

Visit the Duane Morris LLP website to read the full Alert.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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