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Medical Devices Department of Defense (DOD)

Pierce Atwood LLP

PFAS in Maine: Legislature Amends the PFAS in Products Law

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On April 16, 2024, Maine Governor Janet Mills signed into law significant amendments to the PFAS in Products Law. Initially passed in 2021, the PFAS in Products Law required manufacturers of products with intentionally added...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Venable LLP

DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Our Military Personnel

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Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more

Morrison & Foerster LLP

DOJ Releases False Claims Act Statistics for Fiscal Year 2022

On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more

Hogan Lovells

Buy American EO applies domestic preferences for "essential medicines" and "medical countermeasures"

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On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more

McDermott Will & Emery

August 13, 2020, Deadline for Healthcare Providers and Life Sciences Federal Contractors: Ban on Use of Certain Chinese...

McDermott Will & Emery on

Effective August 13, 2020, an Interim Rule jointly issued by the Department of Defense (DoD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) that amends the Federal...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Seyfarth Shaw LLP

New Federal Contract Reporting Requirements Aimed at Protecting Supply Chains Through Detection of Counterfeit Parts

Seyfarth Shaw LLP on

Federal contractors already subject to a myriad of reporting requirements should be prepared for yet another. Effective December 23, 2019, a new Federal Acquisition Regulation (“FAR”) provision entitled “Reporting of...more

Stinson - Government Contracting Matters

Final FAR Rule Mandating GIDEP Reporting of Actual or Suspected Counterfeit Parts Issued: More Questions Than Answers

Supply chain risks are on the rise. Protecting the supply chain is a critical aspect of our national security, health and public safety. Whether parts are electronic or not, if they aren’t what they are represented to be,...more

Robins Kaplan LLP

Financial Daily Dose 11.15.2019 | Top Story: New Jersey Targets Uber Over “Independent Contractor” Worker Classification

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Sending a shot across the bow of the gig economy, New Jersey is seeking nearly $650 million from Uber for “years of unpaid employment taxes for its drivers, arguing that the ride-hailing company has misclassified the workers...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2019

ANTICORRUPTION DEVELOPMENTS - Telecommunications Company Fined $12 Million for FCPA Violations - On August 29, 2019, The Securities and Exchange Commission (SEC) instituted ceaseand-desist proceedings against...more

Hogan Lovells

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general...

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On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

King & Spalding

Also In The News - Health Headlines - September 2015 #3

King & Spalding on

FDA and CDC Issue An Alert on Properly Cleaning Medical Devices – On September 11, 2015, the CDC and FDA issued a joint advisory alerting providers and facilities about properly cleaning medical devices, due to concern with...more

Latham & Watkins LLP

Certifications Under the Trade Agreements Act: 10 Tips to Avoid TAA Traps for the Unwary

Latham & Watkins LLP on

On September 3, 2014, U.K.-based medical device maker Smith & Nephew (the ‘‘Company’’) agreed to pay $8.3 million (plus an additional $3 million in attorney’s fees) to resolve a lawsuit filed under the federal civil False...more

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