Category: Research and Development

COVID-19, Healthcare, Medical Devices, Regulatory Affairs, Research and Development, University Connect

Stark Associates bags a COVID-19 based R&D and Regulatory Submissions Contract for a US Medical Device Manufacturing Co.

Stark Associates announced winning a strategic contract to support Research & Development for COVID-19 protective gear along with regulatory submissions for a Louisville, KY based, Medical Devices Manufacturing Company in partnership with University of Louisville (UofL), KY. The proposed project will see Stark supporting Research & Development for the nanotechnology based color changing biosensors in […]

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Healthcare, Industry News, Medical Devices, Regulatory Affairs, Research and Development

US FDA finalizes Safety and Performance 510(k) registration route

FDA’s final guidance on what the agency calls its Safety and Performance Pathway is based on the Abbreviated 510(k) Program; FDA first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018. Through this market authorization pathway, qualifying device manufacturers would be able to utilize performance criteria identified and approved by FDA to demonstrate […]

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