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As part of this effort, the Population Council is spearheading work to clarify and inform regulatory pathways for MPTs. These are a unique and specialized subset of what regulatory authorities, including the US Food and Drug Administration (FDA), refer to as combination products. The FDA, 21 CFR 3.2(e), defines combination products as “a product comprised of two or more regulated components, any combination of a drug, device, and biological product, produced as a single entity.”

What regulatory guidance exists for multipurpose prevention technologies (MPTs)? A review of key guidance documents and their applicability to MPTs