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

Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians

Certain 510(k)-cleared blood glucose meters do not perform at the regulatory standards for which they were cleared after they hit the market, stakeholders agree. FDA is working on the matter, but no clear plan of action was laid out at a Diabetes Technology Society meeting last week.

The Diabetes Technology Society sponsored a meeting last week entitled, “Do Currently Available Blood Glucose Monitors Meet Regulatory Standards?” The resounding answer from participants: No.

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

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025

EU Harmonized Standards Continue To Trickle In Under MDR

 
• By Amanda Maxwell

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Commission Needs To Prioritize Devices Agency Above All Else

 
• By Amanda Maxwell

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

More from Policy & Regulation

EU Harmonized Standards Continue To Trickle In Under MDR

 
• By Amanda Maxwell

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Medtech Looks For Relief As Trump Hits Pause On Most Tariffs

 
• By Elizabeth Orr

The medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk.

Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
• By Ashley Yeo

The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.