The need for good regulatory practices and medical device regulatory convergence in the Americas has been put in sharp relief by the COVID-19 epidemic.
The Coalition has prioritized regulatory matters assisting in the combat of COVID-19 within the context of its vision and mission towards regulatory convergence.
The Coalition is actively working with key government agencies around the region to identify how the industry can help ensure that providers and patients everywhere have access to the medical technologies they need to help diagnose and fight this deadly virus.
Coalition Members Fight COVID-19
Since the onset of the COVID-19 outbreak, the Coalition member association companies have donated millions of dollars’ worth of medical products and cash to hospitals, foundations and charities around the world. Medical device companies are responding to increased demand by ramping up production wherever possible, coordinating closely with governments to ensure the delivery of supplies where they are most needed, and in some cases, creating new devices and diagnostic tests to help effectively diagnose and treat sick patients.
AdvaMed has assembled a collection of some of the efforts undertaken by Coalition Principal Members’ companies based on public statements.
In Vitro Diagnostic COVID-19 Tests
In vitro diagnostic (IVD) manufacturers have taken key steps to increase patient access to COVID-19 diagnostic testing in laboratories, hospitals, and other testing sites across the country to guide patient care and protect public health.
AdvaMed has compiled a list of companies that have developed IVDs that have received Emergency Use Authorization from the U.S. Food and Drug Administration.
- COVID-19: The Role of In Vitro Diagnostic Testing – Backgrounder
- COVID-19 IVD Testing: What We’re Doing
- AdvaMedDx COVID-19 Test Q&A
- AdvaMedDx COVID-19 Testing Infographic
- COVID-19 Test Production Capacity
MedTech’s Role in Combating COVID-19
The medical technology industry recognizes its crucial role in the health care systems of the Americas, particularly during an unprecedented public health emergency such as the COVID-19 pandemic. This crisis has united us all as in a global fight. The patients our industry serves have always been our No. 1 priority, and we are working around the clock to meet their needs. We are committed as medical technology innovators and manufacturers to working with regional, federal, state, and local authorities to ensure our disaster planning efforts are coordinated, efficient, and effective. Since February 2020, the medtech industry has been mobilizing to this global cause, and we are committed to the following guiding principles in our efforts to conquer COVID-19.
In this section you will find useful information on the following topics:
Coalition Recommendations to the IDB
Coronavirus – Use of Antibody Tests
United States of America Response