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2020 - FDA and MHRA Guidance during the COVID-19 Emergency: Medical Devices and Diagnostic Tests

Date2020-05-25

Deadline2020-05-15

VenueOnline Event, USA - United States USA - United States

KeywordsDiagnostic tests; Fda guidance for covid-19; Mhra medical device guidance

Websitehttps://www.complianceonline.com/fda-and...

Topics/Call fo Papers

Exceptional use applications for non-CE marked devices
Requirements for continuous positive airway pressure (CPAP) devices
Requirements for ventilators
Expedited advice service
Validation of changes to medical devices
Clinical investigations (including protocol deviations)
Diagnostic tests – regulatory pathway
Diagnostic tests – validation requirements

Last modified: 2020-05-07 00:31:38