1. Medtech Insight
  2. >>Device Area

Warning Letter Roundup & Recap – October 2022

The US Food and Drug Administration published two warning letters last month, with one going to aesthetic device company Flawless Beauty and Skin and the other being sent to power chair manufacturer Forcemech International.  

Warning Rubber Stamp

Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

This chart lists device-related warning letters released by the US Food and Drug Administration in October 2022. If an inspection led to the warning letter, the location of the inspected...

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 Durable Medical Equipment

FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health

 
• By Brian Bossetta

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

Latest Philips Recall Linked To Death, Injuries

 
• By Brian Bossetta

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

X-ray Regulations Detailed In New FDA Guidance

 
• By Brian Bossetta

The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.

Device Shortages A Matter Of National Security, Califf Says

 
• By Brian Bossetta

During an online seminar hosted by the Alliance for a Stronger FDA, Commissioner Robert Califf discussed key issues facing the agency, including supply chains, device shortages, and the risk of another pandemic.

More from Device Area

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

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