It is certainly easy, when writing code to accomplish some data science task, to start taking the data on face value. In my mind, the data can simply become what they claim to be. But it’s good to ...

The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online.

A way to add transparency and predictability to the 510(k) decision process would be for Congress to require CDRH’s Office of Device Evaluation (ODE) to use the premarket decision summary template ...

Medtech industry stakeholders have asked the US Food and Drug Administration (FDA) to make significant changes and clarify its proposed guidance on what regulators expect from companies that acquire ...