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Skip to main content Diagnostics & Policy Our Industry & Technology Innovation & Value Regulation Payment Diagnostics Organizations Government Agencies Test-To-Treatment VALID Act Resources Diseases Antibiotic Resistance Antibiotic Resistance and Diagnostic Tests: What You Need to Know The Role of Diagnostic Tests in Antibiotic Resistance The Value of Diagnostics in Combatting Antibiotic Resistance Unleashing the Power of Diagnostic Tests in the Fight Against Antibiotic Resistance Using Diagnostic Tests to Inform Better Care, Save Lives and Fight Antibiotic Resistance Cancer HIV/AIDS Infectious Diseases Healthcare-Associated Infections Zika Virus Diabetes COVID-19 IVD Tests Events Upcoming Events Past Events News Media Contact Press Releases Newsletters About AdvaMedDx About Us Leadership AdvaMedDx Member Companies AdvaMedDX Board Members Join AdvaMedDx Compliance and Ethics Members Log in Log in Resource Center Contact MedTech Responds CenterFor DigitalHealth AdvaMed .org TheMedTech Conference AdvaMed Accel StoryOf MedTech MedTech Responds CenterFor DigitalHealth AdvaMed .org TheMedTech Conference AdvaMed Accel StoryOf MedTech Search form Search GO Log in Resource Center Contact Diagnostics & Policy Our Industry & Technology Innovation & Value Regulation Payment Diagnostics Organizations Government Agencies Test-To-Treatment VALID Act Resources Diseases Antibiotic Resistance Antibiotic Resistance and Diagnostic Tests: What You Need to Know The Role of Diagnostic Tests in Antibiotic Resistance The Value of Diagnostics in Combatting Antibiotic Resistance Unleashing the Power of Diagnostic Tests in the Fight Against Antibiotic Resistance Using Diagnostic Tests to Inform Better Care, Save Lives and Fight Antibiotic Resistance Cancer HIV/AIDS Infectious Diseases Healthcare-Associated Infections Zika Virus Diabetes COVID-19 IVD Tests Events Upcoming Events Past Events News Media Contact Press Releases Newsletters About AdvaMedDx About Us Leadership AdvaMedDx Member Companies AdvaMedDX Board Members Join AdvaMedDx Compliance and Ethics Members Log in Diagnostics & Policy Our Industry & Technology Innovation & Value Regulation Payment Diagnostics Organizations Government Agencies Test-To-Treatment VALID Act Resources Diseases Antibiotic Resistance Antibiotic Resistance and Diagnostic Tests: What You Need to Know The Role of Diagnostic Tests in Antibiotic Resistance The Value of Diagnostics in Combatting Antibiotic Resistance Unleashing the Power of Diagnostic Tests in the Fight Against Antibiotic Resistance Using Diagnostic Tests to Inform Better Care, Save Lives and Fight Antibiotic Resistance Cancer HIV/AIDS Infectious Diseases Healthcare-Associated Infections Zika Virus Diabetes COVID-19 IVD Tests Events Upcoming Events Past Events News Media Contact Press Releases Newsletters About AdvaMedDx About Us Leadership AdvaMedDx Member Companies AdvaMedDX Board Members Join AdvaMedDx Compliance and Ethics Members Log in Log in Resource Center Contact MedTech Responds CenterFor DigitalHealth AdvaMed .org TheMedTech Conference AdvaMed Accel StoryOf MedTech Featured In Vitro Diagnostic COVID-19 Tests In vitro diagnostic (IVD) manufacturers have taken key steps to increase patient access to coronavirus diagnostic testing in laboratories, hospitals, and other testing sites across the country to guide patient care and protect public health. Learn which companies have developed IVDs that have received Emergency Use Authorization from the U.S. Food and Drug Administration. Read more about In Vitro Diagnostic COVID-19 Tests AdvaMedDx VALID Act Resources AdvaMedDx supports the establishment, through legislation, of a modernized and predictable, risk-based diagnostics regulatory framework under the Food and Drug Administration (FDA) to which all developers of in vitro clinical tests (IVCTs) would be subject. Under a modernized new framework, Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs) would be known collectively as IVCTs. The introduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act by Sens. Richard Burr (R-NC) and Michael Bennet (D-CO) in the Senate, and Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) in the House, is a major milestone toward modernizing IVCT oversight, making diagnostics regulatory reform a reality. The VALID Act would aim to establish a single, diagnostics-specific, risk-based regulatory framework under the FDA for all IVCTs. Resources and Background Materials on The VALID Act (introduced 3.5.20) Resources and Background Materials on The VALID Act Discussion Draft (generated prior to bill introduction) Read more about AdvaMedDx VALID Act Resources Recent Newsletters July 2020 May 2020 See All Recent Tweets December 15, 2020 - 12:00pm . @BDandCo is ready to help supply millions of doses of the #COVID19 vaccine by committing to deliver nearly 286 mil… https://t.co/RNEXm59UFS December 14, 2020 - 12:14pm "The [ #COVID19 ] vaccine is no good unless you have a way to get it into the body," says @BDandCo ’s spokesperson. Ge… https://t.co/KXq4eAven8 December 11, 2020 - 1:14pm . @BDandCo ’s manufacturing plant in Nebraska is prepared to deliver nearly 286 mil. syringes and needles by the end… https://t.co/2B4fjUOyNA Diagnostics & Policy Our Industry & Technology Innovation & Value Regulation Payment Diagnostics Organizations Government Agencies Test-To-Treatment VALID Act Resources Diseases Antibiotic Resistance Cancer HIV/AIDS Infectious Diseases Healthcare-Associated Infections Zika Virus Diabetes COVID-19 IVD Tests Events Upcoming Events Past Events News Media Contact Press Releases Newsletters About AdvaMedDx About Us Leadership AdvaMedDx Member Companies AdvaMedDX Board Members Join AdvaMedDx Compliance and Ethics Members Log in Members Only LinkedIn Facebook Twitter Medium AdvaMedDx operates as a division of AdvaMed , the Advanced Medical Technology Association....
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