Holder Of EUA Gets FDA Warning Letter For Not Satisfying MDR Reporting Requirements
Battelle Memorial Institute, an N95 respirator decontamination system maker, has been back-and-forth with regulators about its Medical Device Reporting protocols, which the US FDA says is lacking. Battelle was granted an emergency use authorization by the agency for its CCDS Critical Care Decontamination System to decontaminate N95 respirators back in March.
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The US FDA has issued an emergency use authorization for a Battelle decontamination system to clean N95 masks, which are currently facing a shortage due to the COVID-19 pandemic. The company says it can clean up to 80,000 respirator masks a day from participating health care providers.
Device Week, 30 October 2020 – Medtech Money Influences US Elections; User-Fee Negotiations Kick Off
In this week’s podcast we discuss which political candidates are getting campaign donations from the medtech industry in the 2020 US Senate and House elections, and where the FDA and other stakeholders – including the medtech industry – stand as device user-fee negotiations get underway.
The US agency has added gaseous-phase carbon-dioxide gas analyzers to its list of products that – during the coronavirus pandemic – will not require a new premarket notification to be marketed for remote monitoring.