The FDA has created a new product code, SGT, for over-the-counter PEMF devices. Here is what the FDA PEMF product code means for Class 2 clearance and for devices once filed under TENS.

The FDA's 510(k) review is called a "90-day review," but real clearance often takes five to seven months. Here is the day-by-day FDA 510(k) submission timeline, from submission to decision.

FDA's eSTAR template does more than digitize your 510(k) submission. It reveals exactly what reviewers expect to see, section by section, from your device description through your cybersecurity documentation. Manufacturers who read eSTAR as a blueprint instead of a form are the ones who move through review faster, with fewer Additional Information requests.

IEC 60601-1 is getting its biggest update in nearly two decades. Here's what the 4th Edition changes, why it matters for software-driven and connected devices, and how manufacturers can start preparing now.

CSO Scott Blomberg joined Dr. Mary Blomberg, pediatrician for annual event.

It all begins with an idea.

It all begins with an idea.

It all begins with an idea.