Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Senate: Reusable Medical Device Requirements Must Be Updated

The proposed bill would change requirements for manufacturers.

The Senate Committee on Health, Education, Labor and Pensions wants the requirements for reusable devices to be updated after a number of infections prompted concerns last year related to closed-channel duodenoscopes.

Healio reported that the, Preventing Superbugs and Protecting Patients Act, "would require manufacturers to submit proposed labeling and validated reprocessing data as part of a pre-market 510(k) submission to the FDA, and allows the agency to deny marketing clearance for submissions without this information."

According to the article, there were no objections to the bill, and the committee unanimously voted favorably for the bill.

FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?
List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO