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Episode 108  |  39:01 min

Looking at the Sunset of FDA's Alternative Summary Reporting Program

Episode 108  |  39:01 min  |  11.07.2019

Looking at the Sunset of FDA's Alternative Summary Reporting Program

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This is a podcast episode titled, Looking at the Sunset of FDA's Alternative Summary Reporting Program. The summary for this episode is: The FDA recently decided to discontinue its alternative summary reporting program due to the allegation that millions of medical device reports (MDRs) that included product-related malfunctions were “hidden” and not disclosed to the public. In this episode, Mike Drues of Vascular Sciences joins the show to discuss the pros and cons of the program and what’s expected to happen because of its discontinuation. Some of the highlights of the show include: ● Depending on severity of malfunction, the program gave companies a specified amount of time to report it as part of a summary. ● What created controversy, and why was program cancelled? Potentially fake news headlines, checkbox mentality, and regulatory micromanagement. ● With or without a formal FDA program, companies should follow best practices and not wait for regulations to tell them when and what to do. ● Did program “hide” information? Instead, it reduced redundancy and created a more efficient way to report information. ● FDA needs to clearly identify what events need to be reported; encourage companies to investigate and act to minimize or prevent future problems. ● Quality and Regulatory vs. Product Liability Perspective: Documentation is critical or the kiss of death. There’s never enough publicly available information. ● Special 501(k) program will replace alternative summary reporting program to allow some companies to submit summary reports via spreadsheets. ● Quality over Quantity: More isn’t always better. Program cancellation could do more harm than good and offers opportunity to truly “hide” information.
The FDA recently decided to discontinue its alternative summary reporting program due to the allegation that millions of medical device reports (MDRs) that included product-related malfunctions were “hidden” and not disclosed to the public. In this episode, Mike Drues of Vascular Sciences joins the show to discuss the pros and cons of the program and what’s expected to happen because of its discontinuation. Some of the highlights of the show include: ● Depending on severity of malfunction, the program gave companies a specified amount of time to report it as part of a summary. ● What created controversy, and why was program cancelled? Potentially fake news headlines, checkbox mentality, and regulatory micromanagement. ● With or without a formal FDA program, companies should follow best practices and not wait for regulations to tell them when and what to do. ● Did program “hide” information? Instead, it reduced redundancy and created a more efficient way to report information. ● FDA needs to clearly identify what events need to be reported; encourage companies to investigate and act to minimize or prevent future problems. ● Quality and Regulatory vs. Product Liability Perspective: Documentation is critical or the kiss of death. There’s never enough publicly available information. ● Special 501(k) program will replace alternative summary reporting program to allow some companies to submit summary reports via spreadsheets. ● Quality over Quantity: More isn’t always better. Program cancellation could do more harm than good and offers opportunity to truly “hide” information.

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