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

Pending Mobile Medical Apps Guidance Provokes Heated Controversy

An impassioned debate brewing about FDA’s planned timing for finalizing mobile medical apps guidance bubbled to the surface at a recent meeting of the HHS workgroup tasked with recommending a health IT regulatory framework. Despite pressure to delay the guidance, FDA says it is still pushing ahead.

An HHS-sponsored workgroup convened a conference call last week to discuss its recently released draft recommendations for a comprehensive regulatory structure for health information technology. They ended up spending more time than expected on one very specific point: the timing of FDA’s release of a final guidance on regulating mobile medical apps.

A debate has been brewing about whether FDA should move full steam ahead in issuing the final guidance establishing its...

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

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
• By Marion Webb, Shubham Singh, and Nancy Pham

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

More from Policy & Regulation

Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.