News & Analysis as of October 19, 2024

Medical Devices

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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on 5/29/2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

OIG December Enforcement Summary

Harris Beach PLLC on 1/12/2024

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

Morrison & Foerster LLP on 1/10/2024

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates

Skadden, Arps, Slate, Meagher & Flom LLP on 11/3/2023

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on 8/29/2023

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Increased Regulatory Scrutiny on Health Technology Companies’ Use of Advertising Technologies

Fenwick & West LLP on 3/30/2023

The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

American Conference Institute (ACI) on 6/21/2022

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19

Vinson & Elkins LLP on 3/23/2021

In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more

FDA Identifies Fifteen Hospitals with Failures to Comply with User Facility Requirements for Medical Device Reporting

King & Spalding on 12/12/2016

FDA issued a Form FDA 483 to fifteen prominent hospitals across the United States following inspections that demonstrated failures to comply with the user facility medical device reporting requirements pursuant to 21 C.F.R....more

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