Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

The agency explains that most drug-use-related apps will be considered promotional labeling, but sponsors should sometimes seek advisory comment. US FDA is seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-drug-focused software.

Touch the future,Interface technology, the future of user experience.

US FDA anticipates that sponsors will generally not need to obtain pre-market approval for the output of prescription drug-use-related software, although the agency is also encouraging companies use the voluntary advisory comment process in certain cases.

In officially announcing its discussion proposal in a Nov. 20 Federal Registernotice, FDA recommended drug-makers use the advisory process...

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 Digital Technologies

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 

A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.

Digital Health Roundup: Autonomous Robots, Medtronic’s Surgeon School, Sleep & FDA Rules

In this week's Digital Health Roundup, Medtech Insight's team discusses progress on autonomous surgery, Medtronic's new partnership with IRCAD, FDA cybersecurity news, and C-suite interviews with OpenWater, Flow Neuroscience and EnsoData.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

More from Medtech Insight

Execs On The Move: July 7–11, 2025

 
• By 

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 

A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.