FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. Therefore, the events surrounding this particular Warning Letter preceded the LDT decision. By Steven J.

IT 64

IT Manufacturing Government Clinic 64

FDA Law

JANUARY 5, 2023

But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health. In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease 59

Chronic Disease Government Chronic Condition Vaccination 59

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications.

Healthcare 128

Healthcare IT Education Community 128

FDA Law

JANUARY 24, 2024

That’s a pretty lofty API manufacturing goal, but one that the API Innovation Center (“APIIC”) was charged to take up, consider, and propose some possible solutions. Industry should leverage existing technologies while furthering research and development of innovative and disruptive technologies, in partnership with academia and government.

Supply Chain 69

Supply Chain Manufacturing Government Provider 69