Pressure On Medtech Companies High, And Recalls Frequent, Amidst COVID-19

Medical device manufacturers are operating in what may be the industry’s most challenging business and regulatory environment in recent history, attorneys Bill McConagha and Pamela Amaechi argue in this guest article.

Disease burden concept as a burdened person or businessman pulling a heavy virus cell as a symbol for medical stress or influenza and coronavirus pressure with 3D illustration elements.

As medtech companies work to meet the increased demand for critical equipment and personal protection equipment (PPE) caused by the COVID-19 pandemic, they find themselves operating in what may be the industry’s most challenging business and regulatory environment in recent history.

About The Authors

Bill McConagha is a health care and life sciences partner and Pamela Amaechi is a litigation associate in the Washington, DC, office of law firm Skadden, Arps, Slate,...

The US Food and Drug Administration has devoted an immense amount of time and energy to support the COVID-19 response, and much of its initial focus on using the emergency-use...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By 

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

More from Policy & Regulation

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By 

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.