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Device Week, 29 October 2021 – FDA Fiddles With Breast Implant Rules And Releases Favored Guidances Lists

Executive Summary

On this week’s podcast: The US FDA put some teeth to its regulation of breast implants by issuing several new mandates, including a requirement that surgeons warn patients about the risks of the devices prior to surgery. Also this week the agency released its annual A/B lists of priority guidance documents.

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