Here’s what you should know:
1. Device companies would have 90-days to report a malfunction, compared to the 30-day deadline they currently have.
2. The bill would also allow companies to summarize previously reported malfunctions instead of filing several reports on each case.
3. The bill has its share of varying opinions. Proponents believe the bill would simplify the repetitive reporting process, however critics believe the bill will lessen the number of reported malfunctions.
4. FDA officials said device malfunctions are already underreported.
5. An FDA spokesperson said the malfunction reports would not pertain to malfunctions resulting in patient complications, injuries or deaths.
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