Category: Medical Device

Category: Medical Device

‹ All Posts


Overview of FDA timelines associated with Traditional 510(k)s

Jan 22, 2021
By Becky Ditty, Consultant

Read more ›
Medical Device
FDA traditional 510(k) review timeline MDUFMA performance AI acceptance RTA substantive substantial equivalence

Medical Device Breakthrough Designation

Oct 20, 2020
By Becky Ditty, Consultant

Read more ›
Medical Device
FDA Medical Device Breakthrough Device Request for Breakthrough Device Designation Breakthrough Device Designation Request

FDA Is Holding Virtual Panel Meetings for Medical Devices

Aug 11, 2020
By Christy Foreman, MBE, Senior Consultant, Medical Devices

Read more ›
Medical Device
FDA Medical Device Panel Meeting

New Policy for SARS–CoV–2 Serology Tests

May 30, 2020
By Cheng Zhang, Senior Consultant, Medical Devices

Read more ›
Medical Device
serology EUA antibody test antibody