FDA Law

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. FDA, Performance Report to Congress: Medical Device User Fee Amendments FY 2022, at 13-18, [link]. [14]

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. based upon the anticipated clinical benefit of earlier patient access to the product.”.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Today's Hospitalist

JUNE 7, 2025

Key takeaways: Hospitalists will increasingly have to manage inpatients taking GLP-1s. Because many medications can cause weight gain, doctors should consider more weight-neutral alternatives. Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries.

Hospital 65

Hospital Management Diabetes Patients 65

FDA Law

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

Management 95

Management Provider Specialization Clinic 95

GeriPal

NOVEMBER 17, 2022

You’re independent, drive in and out, and the more help you need, so for example, now you need somebody to help with medication administration. And when I was getting my PhD, I wanted to find something that spoke to me, and I had been doing clinical work in nursing homes. So you have your room and board, very little help.

Community 97

Community IT Mental Health Medical 97

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115