Remove Blog Remove Engineering Remove Individual Remove Specialization
article thumbnail

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

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

article thumbnail

Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

New South Family Medicine and MedSpa

However, people need to understand what works best for them individually. blog":{"type":"Static","pageId":"tomo1"},"./medspa-policies":{"type":"Static","pageId":"c8gi2"},"./event-list":{"type":"Static","pageId":"lmi71"},"./general-clean":{"type":"Static","pageId":"u6anc"},". Food has the power to regenerate the new you!

article thumbnail

Do You Hear What I Hear? One Year of OTC Hearing Aids

FDA Law Blog

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.