Warning Letter Roundup & Recap – 21 April 2020
In the only device-related warning letter released by the US FDA this week, a maker of intrauterine insemination and intracervical insemination kits was cited for quality systems, Medical Device Reporting and premarket violations.
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Medical device manufacturers initiated fewer recalls in the third quarter of 2020. Check out our Q3 recalls infographic.
The coming pilot program would give the US FDA remote access to a manufacturer’s records. It’s another approach the agency wants to try as it feels out the best way to virtually evaluate regulatory compliance during the COVID-19 pandemic.
The US FDA is assessing via a pilot program whether the use of video is helpful when investigators perform remote facility inspections. Meanwhile, the agency’s device center is “working on alternative approaches for assessing a firm’s quality management system,” an FDA official says.