Medical Device Integrity Act Introduced

Sens. Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) have introduced the Medical Device Integrity Act to give FDA the authority to request records and require that medical device manufacturers comply with the requests. In a statement, the senators say the measure will better prepare the U.S. for future pandemics and support Made in America medical supplies.

Under current law, the statement says, FDA can request records from medical device manufacturers, but there is no requirement for the manufacturers to comply, even in a pandemic. “Medical devices are an incredibly broad category,” they say, “ranging from Band-Aids to ventilators. Most PPE (personal protective equipment) is also considered a medical device, including gloves and masks. From February to May of 2021, approximately 40% of medical device manufacturing facilities did not comply with FDA record requests.”