FDA defends itself against criticism over inadequate medtech software regulation
This article was originally published in Clinica
The FDA has responded to a media report which highlighted the vulnerability of medical devices to software defects which, in turn, put patients at risk.
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Not only is the EU due to be endorsing key guidance documents this week, but recent headline topics, including appointing expert panels and the delay in setting up the Eudamed database feature on end of week Medical Devices Coordination Group meeting agenda.
The European Parliament is about to sign off corrigenda to the Medical Devices and IVD Regulations. The headline news is a longer transition period for a huge swathe of class I products, but there are other changes too.
The two-year delay to Eudamed was a Commission decision. Now the competent authorities are fighting back and the issue is to be discussed at the level of the Council of the European Union on December 9 to avoid “heavily burdensome administrative transitional solutions.”