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BIO Comments on FDA Guidance - IVD Device Studies Frequently Asked Questions

December 17, 2019

On December 16, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Food and Drug Administration’s (FDA’s) Notice to Public of Website Location of CDRH Fiscal Year 2020 Proposed Guidance Development; In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions. BIO appreciated FDA’s effort to evaluate this 2010 guidance to ensure it remains useful and up to date. BIO's members have found this guidance very useful but acknowledge that certain portions should be updated to reflect current law, regulation and FDA practice. BIO requested that the guidance be revised to reflect FDA’s current thinking and practice to better describe FDA’s expectations with respect to use of IVDs in drug trials and companion diagnostic co-development. 

BIO is the world's largest trade association representing approximately 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. Specifically, many of BIO’s members develop, market, or are impacted by diagnostic technologies for a variety of research, investigational, and clinical uses. BIO’s members also develop therapeutic products that are guided by diagnostics tests that provide the right treatment for the right patient at the right time—the essence of the modern precision medicine paradigm.

Download Full Comments Below
Final BIO Comments on FDA Guidance - IVD Device Studies Frequently Asked Questions
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