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More Guidance Coming On Common Combo Product Designation Mistakes

 
• By Derrick Gingery

US FDA's Office of Combination Products hopes Q&A guidance will help lower high refusal rate on requests for designation.

More guidance is expected from the US FDA in the coming months to help combination product sponsors avoid mistakes in their requests for designation and reverse a low filing rate.

Nearly 87% of the designation requests received in fiscal year 2017 were not filed or withdrawn because of missing information...

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More from Combination Products

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

 
• By Marion Webb

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 Elizabeth Orr

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 Vibha Sharma

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 Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

 
• By Marion Webb, Brian Bossetta, Natasha Barrow, Elizabeth Orr, and Shubham Singh

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

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.

GE HealthCare Announces US Launch Of Longer Half-Life PET MPI Agent For Ischemia Detection

 
• By Shubham Singh

GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.