Ventilators: EU & FDA Standards

In this newsletter, you will find FDA and EU CE mark regulations for ventilators. Under FDA, types of risks, types of devices and their classification, submission procedure, FDA process timeline, authorization process under EUA and duration authorization are discussed. Under EU Regulations, the medical devices are arranged as per their risk level, namely, high, medium, low and lowest. The newsletter also mentions temporary permits, an emergency application process for the UK.