Zdrowie i gospodarka · 26/09/2019

FDA Releases Draft Guidance on Electronic Submissions for Medical Devices

The Food and Drug Administration (FDA) is releasing a draft guidance on electronic submissions for medical devices, mandated by the FDA Reauthorization Act of 2017 and the Medical Device User Fee Amendments of 2017. The guidance aims to establish standards for electronic submissions, timelines for implementation, and criteria for exemptions.