Postmarket modifications to combination products marketed via pma or 510(k)
Babson, Janna Lynn
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The Office of Combination products has established guidance documents for regulatory requirements surrounding combination products. However, there is a lack of guidance on when a modification to an already marketed combination product triggers a need for a new postmarket submission for devices that have entered the market via a premarket notification (510(k)). Approximately 80% of all combination product submissions gain market entry via a 510(k), indicating a strong industry need for clarification of regulatory requirements for these product types. Examination of guidance documents, review of formal public positioning of industry organizations, and assessment of industry comments on relevant guidance documents provides insight into the current thinking of the Food and Drug Administration (FDA) regarding these product types. Additionally, guidance documents for combination products are limited in declaring submission types for postmarket modifications of drug-device or biologic-device combination products approved to market under a PMA. A review of guidance documents for standalone drugs and biologics in combination with the guidance document “Submissions for Postapproval PAS Modifications to a Combination Product Approved Under a BLA, NDA, or PMA” will afford insight to the necessary submission type when there is a modification to the drug or biologic constituent part. The summation of this work may provide regulatory professionals a better perception of actual regulatory requirements to maintain regulatory compliance, and strategies to expedite entry of the modified product into the marketplace.