Blog Clinic Engineering Specialization 
FDA Law Blog
JULY 10, 2023
In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. an administrative appeal) under 21 CFR 10.75
FDA Law Blog
FEBRUARY 22, 2023
In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study.
FDA Law Blog
NOVEMBER 8, 2023
Koblitz & Philip Won — The first anniversary is always special. For those who are unfamiliar with the rule, let us briefly explore its history across three different administrations (see our previous blogs: here , here , and here ). By Jeffrey N. Gibbs & Sara W. In some measurable ways, the rule has been a success.
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