South Carolina Research Authority seeks a contractor to determine the regulatory pathway for U.S. Food and Drug Administration (FDA) clearance/approval for up to five early-stage medical devices. Such regulatory evaluations typically include identification of potential pathways through the FDA and into the U.S. market based on what types of marketing claims will be made to patients and providers regarding the intended use of the product and what types of technologies will be integrated prior to marketing. The devices are in the fields of neonatal feeding, orthopedic fractures, bioink for tissue engineering, and breast tumor biopsy and . . .

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RFP | April 29, 2019

South Carolina Seeks Medical Device Regulatory Strategy Services

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