BIO Comments Submitted to FDA on Regulation of LDTs
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The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled <em>Framework for Regulatory Oversight of Laboratory Developed Tests </em>(the "Framework Guidance") and <em>FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) </em>(the "Notification Guidance) (Collectively the "LDT Guidance").</p>
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (the "Framework Guidance") and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (the "Notification Guidance) (Collectively the "LDT Guidance")...
