This article was originally published in RAJ Devices
Legislative setback for European Commission proposal on mercury
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The latest medical device user fee (MDUFA) reports seem to indicate the percentage of premarket applications that receive a major deficiency letter are starting to come back up. US FDA says a key reason for the letters is because of insufficient testing information from device sponsors. The agency offers some steps that sponsors can take to avoid getting one of the dreaded missives.
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.
“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says. Warning submitted in March said falsifying data was found in making batch release decisions related to whether certain sterile ophthalmic drugs contained viable microorganisms.