Global Medical Device Podcast Powered By Greenlight.guru
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020
- Author: Vários
- Narrator: Vários
- Publisher: Podcast
- Duration: 0:34:25
- More information
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Synopsis
What did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mistakes during your next quality system inspection.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences. Together, Mike and Jon discuss the FDA FY2020 data for medical device quality system inspections and evaluate the top three most cited QSR clauses that resulted in 483 observations.Some highlights of this episode include:The volume of inspections and number of findings, such as 483 observations and warning letters, were down - partially due to the COVID pandemic.Other reasons may include whether remote inspections are effective or even allowed. However, the number of 483s issued against medical device quality systems decreased by 50% in 2020.Top 3 Cited Claims: CAPAs, complaints, and design controls made up about 35% of all 483 observations issued by the FDA in 202