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IDSA Comments Re Draft Diagnostic Accuracy and Innovation Act (PDF)
Diagnostic Accuracy and Innovation Act (DAIA) that builds upon previous efforts to establish a modern framework for the regulation of LDTs, as FDA offers technical assistanc...
http://www.idsociety.org/.../IDSA Comments Re Draft Diagnostic Accuracy and I... - 8 pages

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Joint IDSA HIVMA Comments to FDA on Reclassification of HIV and HCV Diagnostic Tests (PDF)
We urge the FDA to classify these viral diagnostic tests as Class II. For years, IDSA has stressed the need for innovative diagnostic devices to improve care for patients...
http://www.idsociety.org/.../Joint IDSA HIVMA Comments to FDA on Reclassifica... - 4 pages

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IDSA Comments to FDA on Antimicrobial Susceptibility Test Devices (PDF)
Challenges of Diagnostic Devices” as part of an ongoing dialogue generated by the 2016 FDA draft guidance, “Coordinated Development of Antimicrobial Drugs and Antimicrobial...
http://www.idsociety.org/.../IDSA Comments to FDA on Antimicrobial Susceptibi... - 5 pages

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IDSA Comments to CMS Re CY 2018 Clinical Laboratory Fee Schedule Test Codes Preliminary Determinations (PDF)
Protecting Access to Medicare Act of 2014 (PAMA). We recognize that CMS is committed to developing an equitable payment system that will improve patient access to diagnosti...
http://www.idsociety.org/.../IDSA Comments to CMS Re CY 2018 Clinical Laborat... - 4 pages

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IDSA Letter of Introduction to ASPR Robert Kadlec (PDF)
The Infectious Diseases Society of America (IDSA) would like to take this opportunity to congratulate you on your appointment as the new Assistant Secretary for Preparedness...
http://www.idsociety.org/.../IDSA Letter of Introduction to ASPR Robert Kadle... - 2 pages

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IDSA Introduction to FDA Commissioner Gottlieb (PDF)
As you assume this important role, I want to offer the Infectious Diseases Society of America (IDSA) as a resource and a partner for advancing policies to improve patient...
http://www.idsociety.org/.../IDSA Introduction to FDA Commissioner Gottlieb (... - 5 pages

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IDSA Comments to FDA on Laboratory Developed Tests (LDT) Discussion Paper (PDF)
Our society has closely followed the FDA’s draft guidance, public stakeholder workshop, and January 2017 discussion paper proposing to regulate laboratory developed tests...
http://www.idsociety.org/.../IDSA Comments to FDA on Laboratory Developed Tes... - 3 pages

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IDSA Comments on FDA Notice of Meeting on Microbiology Devices Panel (PDF)
IDSA greatly appreciates this opportunity to provide comments. We urge the FDA to classify viral load tests for these transplant associated viruses as Class II. Over the...
http://www.idsociety.org/.../IDSA Comments on FDA Notice of Meeting on Microb... - 3 pages

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IDSA Leads Response to FDA Guidance on Next Generation Sequencing (PDF)
Thank you for the opportunity to submit written comments on the draft guidance entitled “Infectious The American Society for Microbiology (ASM) is the largest single life...
http://www.idsociety.org/.../IDSA Leads Response to FDA Guidance on Next Gene... - 7 pages

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IDSA Shares Evidence on Diagnostics for Transplant Viruses with FDA (PDF)
However our society remains concerned that the FDA’s draft guidance to regulate laboratory developed tests (LDTs) will negatively impact the care of patients being evaluated...
http://www.idsociety.org/.../IDSA Shares Evidence on Diagnostics for Transpla... - 4 pages

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