Senate’s Medical Device Integrity Act would require medical device manufacturers comply with FDA record requests

With as many as 40 percent of medical device manufacturing facilities refusing to submit records when asked by the U.S. Food and Drug Administration (FDA), U.S. Sens. Tammy Baldwin (D-IL) and Bill Cassidy (R-LA) have proposed a bill that would encourage compliance.

The requests were made between February and May of this year. The Medical Device Integrity Act (S.3395) would guarantee that the FDA could gain greater insights into device manufacturers after approval. A strengthened remote records authority would also allow the FDA to crack down on counterfeit devices at home and abroad.

“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,” Baldwin said. “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.”

The COVID-19 pandemic exposed issues with the existing supply chain, as well as the FDA’s abilities to oversee it. Traditionally, the agency has relied on its existing authority to request records in advance of or in place of inspections of facilities that manufacture, prepare, propagate, compound, or process drug products. That authority does not include manufacturers of medical devices, though, and the issue was compounded when many FDA inspections were halted, forcing the agency to rely more on remote records requests.

Currently, nothing requires medical device manufacturers to comply with such requests. This became an area of particular concern, given how much of the U.S. personal protective equipment supply was manufactured overseas.

“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,” Cassidy said. “This legislation supports production back home and strengthens our defense against future outbreaks.”

The bill has been referred to the Senate Committee on Health, Education, Labor, and Pensions.