The FDA ordered the exemption five types of Class II medical devices from 510(k) requirements. This decision aims at releaving manufacturers of those devices from some regulatory burden.

Meditrial has extensive experience on regulatory matters relating to medical device in the US and can help manufacturers to take the right actions and ensure compliance.

The order lists exempt and non-exempt product codes for five types of devices and details limitations to the exemptions for four of the device types. Details are shown in the table:

For more details, please see the order 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.