Device Week, 29 October 2021 – FDA Breast Implant Rules & Favored Guidance List

Citeline Podcasts

English - October 29, 2021 18:33 - 10 minutes - 7.27 MB - ★★★★★ - 24 ratings
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On this week’s podcast: The US FDA put some teeth to its regulation of the 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 list of priority guidance documents.
Medtech Insight articles addressing topics discussed in this episode:
• FDA Strengthens Safety Requirements For Breast Implants
https://medtech.pharmaintelligence.informa.com/MT144648/FDA-Strengthens-Safety-Requirements-For-Breast-Implants
• FDA Guidance Priorities For FY 2022 Include Transitioning EUAs; List Includes CDS Software Again
https://medtech.pharmaintelligence.informa.com/MT144629/FDA-Guidance-Priorities-For-FY-2022-Include-Transitioning-EUAs-List-Includes-CDS-Software-Again