WASHINGTON – Senators Bill Cassidy, M.D. (R-LA) and Tammy Baldwin (R-WI) today introduced the Medical Device Integrity Act to better prepare the U.S. for future pandemics and support Made in America medical supplies. The bipartisan bill would ensure our communities and frontline workers have high-quality medical devices, such as personal protective equipment (PPE), and address counterfeit devices by giving the Food and Drug Administration (FDA) the authority to request records and require that device manufacturers comply with these requests.
“When the pandemic broke, China embargoed PPE manufactured by U.S. companies that was supposed to be sent to the U.S. This endangered Americans,” said Dr. Cassidy. “This legislation supports production back home and strengthens our defense against future outbreaks.”
“Unfortunately, it is not ‘if,’ but rather ‘when’ the world will face another pandemic, and as a country, we must be better prepared to keep our friends, neighbors, and frontline workers safe,” said Senator Baldwin. “The bipartisan Medical Device Integrity Act will ensure that the medical equipment – like masks, gloves, PPE, and more – we rely on are of the highest quality. By rooting out poor quality medical equipment that is often made abroad, this legislation will also support our Made in America economy, supporting jobs across Wisconsin and the country.”
Background
Under current law, the FDA can request records from medical device manufacturers, but there is no requirement for manufacturers to comply, even in a pandemic. Medical devices are an incredibly broad category, ranging from Band-Aids to ventilators. Most PPE is also considered a medical device, including gloves and masks. From February to May of 2021, approximately 40 percent of medical device manufacturing facilities did not comply with FDA record requests.
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