Module 15 Presentations

15/04/2024

Guidance Helping Clinical Strategic Thinking: Breakthrough Technology Designation

• Expedite device

2011 – 2015

Predecessor programs: Innovation Pathway and Expedited Access Pathway (EAP)

development and review for certain medical devices • Work with sponsors to define a roadmap from early stages of device development to FDA marketing authorization • Breakdown perceived barriers • Collaboration & interaction

21 st Century Cures gives FDA authority to establish program for review of certain devices representing breakthrough technologies {now in Section 515B of FD&C Act}

Dec 2016

Guidance issued to clarify policies and procedures for implementing the Breakthrough Devices Program

Dec 2018

The Organisation for Professionals in Regulatory Affairs

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BREAKTHROUGH DEVICES: PROCESS

Granted: Use mechanisms for obtaining FDA Feedback

Breakthrough Device Designation Request

Submission for “expediated” review

Prepare Marketing Submission

• Prioritized review – jump to front of que • Management oversight by FDA • Quicker pre-submission review cycle • Establishes a pre-/post-market balance

• If denied, traditional pathways are still available

The Organisation for Professionals in Regulatory Affairs

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