By Stewart Eisenhart, Emergo Group
A new discussion paper from the US Food and Drug Administration identifies challenges to developing effective regulatory oversight of 3D printed medical devices used in patient point of care (PoC) settings, and lays out potential regulatory approaches for such devices.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
By Stewart Eisenhart, Emergo Group
The U.S. Food and Drug Administration has set a 2.5% increase for 2022 fiscal year fees charged to medical device market applicants seeking 510(k) clearance, Premarket Approval (PMA), De Novo or other registrations in order to sell their products on the US market.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
By Stewart Eisenhart, Emergo Group
Medical device and IVD manufacturers reported healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.