1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

DexCom Hit With FDA Warning Letter For Adverse Event Deficiencies

The firm says an FDA warning letter it received cites violations based on “recent updates” to FDA’s Medical Device Reporting program made in a draft guidance last year. But FDA emphasizes that it does not take enforcement actions based on how a company implements a guidance document, draft or final.

DexCom Inc. says FDA investigators concluded last November that the firm’s adverse event reporting system was not compliant with “recent updates” related to the Medical Device Reporting regulation, resulting in a warning letter the firm announced on March 25. But FDA says that is a misstatement of the letter’s content, and that the agency does not take enforcement action based on how a company implements a guidance document, draft or final.

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
Start Free Trial

Already a subscriber?

More from Regulation

Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Abbott, J&J Reaffirm 2025 Profit Guidance Despite Growing Tariff Uncertainties

 
• By Marion Webb

Abbott and J&J reassured investors they will maintain their 2025 profit forecasts. Abbott projects $5.05 to $5.25 per share and plans a new $500m investment in manufacturing and R&D sites. J&J anticipates $400m in tariff-related costs but committed $55bn in US investment over four years.

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

More from Policy & Regulation

Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Abbott, J&J Reaffirm 2025 Profit Guidance Despite Growing Tariff Uncertainties

 
• By Marion Webb

Abbott and J&J reassured investors they will maintain their 2025 profit forecasts. Abbott projects $5.05 to $5.25 per share and plans a new $500m investment in manufacturing and R&D sites. J&J anticipates $400m in tariff-related costs but committed $55bn in US investment over four years.

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.