Why Are One-Third of MAUDE Reports a Problem?

Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing MAUDE safety reports and taking a look at what the issues are with them. More specifically, we’re digging in to find out why almost a third of the reports are delayed or incomplete. We’ll get insight on what these reports are, if they are important, and what should be done to improve that 30% figure. During this conversation, the following questions are addressed:

• First, Mike, if you would, please explain what the Manufacturer and User Facility Device Experience (MAUDE) Database is.
• What are the MAUDE reporting requirements?
• How well does the MAUDE reporting system work?
• Are there consequences for a delayed or incomplete report?
• Given the statistics, is the MAUDE database a reliable source of information for medical device manufactures? for clinicians? for patients? for anyone?
• What should manufacturers do?
• What should the FDA do?
• What else is important?
• What are today’s takeaways?

Listen to this discussion and see if your company might have an issue with submitting a correct MAUDE report. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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