FDA 2019 Lapse in Funding Information

Agency operations continue to the extent permitted by law necessary to address imminent threats

•  Handle and respond to emergencies
• Mission critical surveillance for significant safety concerns with medical devices and other medical products

Activities funded by carryover user fee funds

• NO acceptance of regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period

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Breakthrough Devices Program

Goal

• Provide timely access to patients and health care providers by speeding up development, assessment, and review (PMA, 510(k), De Novo)
• Replaces Expedited Access Pathway and Priority Review for medical devices

Benefits

• Efficient FDA interaction during premarket review phase
• Prioritized review of submission

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Safer Technologies Program (STeP)

As part of Medical Device Safety Action Plan, STeP is for devices that treat less serious conditions and innovate on safety 

• For devices that do not otherwise meet ‘breakthrough device’ criteria
• Has the potential to be significantly safer than currently available alternative treatments or diagnostics
• Additional details to be provided later

Substantial safety innovations could include

• Reduce occurrence of serious adverse event or other safety issue
• Address known device failure mode or common user error
• Provide for significant safety advantages for users

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Digital Health Software Precertification (Pre-Cert) Program: v1.0 Working Model

Objective

• Streamlined and efficient regulatory oversight of software-based medical devices
• Manufacturers who have demonstrated robust culture of quality and organizational excellence
• Manufacturers who are committed to monitoring real-world post-marketing performance

Proposed key components 

• Excellence Appraisal: Five excellence principles of patient safety, product quality, clinical responsibility, cybersecurity responsibility, and proactive culture
• Review: De Novo classification process with review corresponding to excellence principles
• Streamlined Review: Interactive review of  software product with special controls and TPLC approach
• Real-world Performance: Type of information about how software product is performing with patients and emerging risks

2019 TEST PLAN

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Sentinel System – Five-Year Strategy 2019-2023

Sentinel System

• Core feature of medical product post-market safety surveillance armamentarium
• Proactively monitors product safety, methodological innovation, real-world evidence
• Roadmap to focus on innovations emerging from new data science disciplines (NLP, ML), , expand access and use of EHRs

Five Strategic Aims

• Enhance and expand foundation, including data, infrastructure, operations and technology
• Augment safety analysis capabilities using advanced data science, signal detection
• Accelerate access to and broaden use of real-world data  for real-world evidence
• Broaden stakeholder ecosystem
• Disseminate knowledge and advance regulatory science

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Image credits: FDA