Module 15 Presentations
15/04/2024
Differences and Comparison of US Expediated Process Available to Manufacturers
• Breakthrough Designation https://www.fda.gov/medical-devices/how study-and-market-your-device/breakthrough devices-program
• STeP Program https://www.fda.gov/medical-devices/how study-and-market-your-device/safer technologies-program-step-medical-devices • Available for existing technologies or existing disease condition
Available for new and novel devices
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Unmet medical need
Makes a device type safer
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• Submission moves to front of que
• More interactive review process
• Prioritise on FDA discussions / feedback process
• Prioritise on FDA discussions / feedback process
There is no equivalent process for these in the European Union or UK
The Organisation for Professionals in Regulatory Affairs
17
Can I use my device’s European clinical data to support approval?
The Organisation for Professionals in Regulatory Affairs
18
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