House approves bill extending time for devicemakers to report defects: 3 takeaways

The Food and Drug Administration user fee reauthorization bill, which House representatives passed Wednesday, contains a measure that would triple the amount of time device companies have to report product issues, reports Star Tribune.

Here are three things to know.

1. If approved, the bill would give devicemakers 90 days, instead of 30, to report product malfunctions to the FDA. The legislation would also permit companies to summarize previous product malfunction reports, rather than filing detailed reports for each case.

2. The bill's advocates say it will eliminate the repetitive process for reporting known product malfunctions, while critics believe the policy change could cause underreporting of malfunctions, which the FDA admits is already an issue.

3. The legislation would maintain a 30-day reporting period for device issues that directly cause patient injury.

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House passes FDA user fee reauthorization bill
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