SMART quality & compliance
Overview of guidance and information published by the EMA and the FDA concerning the current COVID-19 epidemy
Temporary authorizations issued in response to the COVID-19 pandemic FDA enforces policy for infusion pumps and accessories during the coronavirus disease 2019 To help facilitate the availability of infusion pumps, the FDA does not intend to object to limited modifications to the indications, functionality, hardware, software, design, or materials of FDA-cleared devices used to support patients who require continuous infusion therapy, without prior submission of premarket notification. FDA guidance issued on April 5, 2020. FDA enforces policy for clinical electronic thermometers during the coronavirus disease 2019 public health emergency. To help ensure the availability of equipment, the FDA does not…
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