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.

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