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AdvaMedDx Priorities 2021

AdvaMedDx, a division of the Advanced Medical Technology Association (AdvaMed), represents manufacturers of

innovative in vitro diagnostic (IVD) tests in the U.S. and abroad that are leveraged each day by clinicians across health

care settings – including those that are front-line tools in the fight against COVID-19. Diagnostic tests influence

seventy percent of all health care decisions1, including by enabling early detection of disease, determination of the

most appropriate clinical pathway for patient care, monitoring treatment and as fundamental support for the cutting-

edge practice of precision or personalized medicine.

COVID-19 Response

In 2020, the IVD industry rapidly mobilized to develop and radically scale-up manufacturing to meet the

unprecedented demand for quality COVID-19 diagnostics and other critical tests. AdvaMed and AdvaMedDx have

prioritized supporting MedTech’s mobilization to the pandemic to protect patients and public health through the

development of and advocacy on a wide range of policy matters both administrative and legislative to foster

innovation, expand access to testing and to bolster testing infrastructure and capability for future pandemic

preparedness.

Further, AdvaMed and AdvaMedDx have also proactively established key initiatives including:

• The MedDeviceNetwork platform: Designed to connect medical device and diagnostics companies with

component suppliers to help quickly boost production and distribution of vital technologies and to reinforce

complex supply chain needs; and

• The AdvaMed COVID-19 Testing Supply Registry: The Registry provides real-time, actionable data on COVID-19

testing supplies shipped to laboratories nationwide – delivered via weekly reports to federal and state policy

makers in their pandemic responses. The Registry includes participation from fourteen leading diagnostics

manufacturers whose tests together comprise ~90% of the COVID-19 tests on the market in the U.S.

AdvaMedDx’s broad agenda for 2021, that include several critical COVID-19 testing priorities, spans Payment and

Coverage, Regulatory Affairs (FDA matters), and Global matters. The agenda will be updated to reflect industry

priorities in a changing environment.

Regulation: Promoting Modernized

Regulatory Oversight of Diagnostics

AdvaMedDx supports policies to advance predictable and

risk-based regulatory pathways and policies that recognize

advancing science and innovation are essential to ensuring

patients and providers have timely access to new, quality

clinical diagnostic tests and technologies. In 2021,

AdvaMedDx will strive to:

• Advance Legislation to Establish a Diagnostic-Specific,

Risk-Based Approach for All Diagnostic Tests (Tier I): In

early 2020, bi-partisan, diagnostics regulatory reform

legislation, the Verifying Accurate Leading-edge IVCT

Development (VALID) Act was introduced in the House

and Senate. AdvaMedDx seeks the reintroduction of an

improved VALID Act early in 2021. Diagnostics regulatory

reform would provide clarity to regulatory oversight of

all in vitro clinical diagnostics tests – both the IVD tests

manufactured by AdvaMedDx members for the

commercial market that are currently regulated by the

Food and Drug Administration (FDA) as medical devices

and not specifically as diagnostics, as well as diagnostics

tests developed by laboratories, including hospital

laboratories, known as Laboratory Developed Tests

(LDTs), which, under current HHS interpretation, are not

subject to FDA premarket review absent notice-and-

comment rule making. Establishment of a single,

predictable regulatory framework tailored to all clinical

diagnostics tests would include modernized regulatory

pathways and policies to foster innovation in diagnostics

development to speed patient and clinician access to the

latest diagnostics. In partnership with our laboratory and

patient organization partners, we will continue our work

to improve and expedite the advancement of the VALID

Act through the legislative process in 2021