FDA Law Blog

JULY 10, 2023

By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. The stakes are high.

Provider 75

Provider IT Engineering Medical 75

GeriPal

NOVEMBER 21, 2024

Acceptance. All of these are ways we cope with stressful situations. Some we may consider healthy or unhealthy coping strategies, but are they really that easy to categorize? Isn’t it more important to ask whether a particular coping behavior is adaptive or not for a particular person,in a particular time or situation? Amanda, welcome to GeriPal.

Illness 125

Illness IT Patient-Centered Patients 125

GeriPal

JUNE 15, 2023

Hallucinations, or when the AI lies or b *s, then denies it When the AI approaches sentience, is it ethical to unplug it? I’m sure this is a subject we will return to, given the rapid progress on AI. But then it asked me, “Oh, that sounds really interesting. Who are you going to be talking to?” ” And I said, “Sure.”

IT 99

IT Patient-Centered Patients Healthcare 99

GeriPal

JULY 21, 2022

We learned this and much more, and I had a great time making engine noises singing the Woody Guthrie song “driving in my car.” . There is a dearth of Certified Driving Rehab Specialists: 12 for the entire state of Colorado! Additional Links: (A to Z – under driving). OT programs). An Advance Directive for When Driving Becomes Unsafe.

IT 102

IT Families Family Diagnosis 102