US: FDA issues final guidance on multiple function device products
The FDA finalized a guidance for sponsors regarding the FDA´s review of medical products that contain both medical and non-medical functions.
Meditrial has extensive experience with assisting sponsors in regard of FDA requirements for medical devices and software as a medical device.
The new from the FDA addresses provisions of Cures Act that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new guidance clarifies how – and when – FDA will assess the impact of the “other functions” of a product when those functions are not the subject of a premarket review.
For more details, please see the guidance from the FDA.
Meditrial can help, Contact us now
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
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FDA Breakthrough Device Acceleration
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
