FDA's Drug Center Permits Some Combo Product Software To Be Submitted As DMFs

New draft guidance from the US agency allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file (DMF), potentially streamlining the assessment process.

Data synchronization of health book between smartwatch and smartphone in male hands
Sponsors have to explain in their applications why the device constituent part should be included in a DMF, and not an IND, NDA, ANDA or BLA

The US Food and Drug Administration moved to further streamline the combination product approval process by allowing some electronic or software constituent parts to be submitted as drug master files.

When the agency's Center for Drug Evaluation and Research (CDER) is leading the assessment of the application, sponsors now can use a Type V drug master file (DMF) to describe electronics or software "that is planned to be used as a platform," or in multiple CDER-led combination products, the FDA said in new 

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 Combination Products

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By 

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

Recall Alerts For Boston Scientific, Philips, J&J, And More

 
• By 

The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.

EU Pilots Streamlined Approach To Multinational Combination Product Trials

 
• By 

EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.

More from Device Area

Digital Health And AI Tools Advance Cardiac Event Prediction, SCAI 2025 Data Show

 
• By 

Out-of-hospital cardiac arrest remains one of the most challenging and resource-intensive emergencies in cardiovascular care. At SCAI 2025, clinicians presented a novel algorithm that improved triage decisions and reduced unnecessary interventions.

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By 

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.