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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

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  • 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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Capture.JPGDigital 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

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