Warning Letter Roundup & Recap – 21 May 2019
Two automatic external defibrillator manufacturers and an orthopedics firm were the subjects of the three warning letters US FDA released this week.
You may also be interested in...
In 2018 the US FDA and the Medical Device Innovation Consortium (MDIC) embarked on a mission to recast corrective and preventive action – CAPA – as a continuous learning tool, rather than a place where problems often go to linger, be ignored and never die. On this week’s podcast we talk about the latest in those efforts, including a pilot program that’s testing a risk-based CAPA framework.
The US agency on 29 May gave two additional tools to COVID-19 test developers: an emergency use authorization template for tests using at-home sample collection kits, and a reference panel for the disease.
Sponsors of PMA or HDE-authorized devices can make some modifications in response to COVID-19 without first alerting the US FDA under a recent guidance document.