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

Unmet medical need

Makes a device type safer

• 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

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