FDA regulation of Medical Device Data Systems has changed significantly over the years. This, together with the blurred line between MDDS and general health information technology, interfaces between MDDS and regulated medical devices, the actual criteria for deciding if something is classified as a Medical Device Data System, and different regulatory requirements outside the US...Read More

The FDA release a final guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on October 30, 2017. This supersedes “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998. This guidance defines the process for De Novo submissions for devices with no...Read More