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ViewAttendees 27

Medical Devices

Domain: Product Development & Registration

Knowledge Area: Regulatory Guidance

Medical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified Bodies

Friday, May 12, 2023
10:45 – 11:45 CEST
Location: Pearl 1

Supported By
Description: In this presentation, former FDA CDRH and former BSI regulatory experts discuss the most received deficiencies associated with software in FDA submissions (e.g. 510(k), De Novo) and EU technical documentation.

This session will present case studies, best practices, and solutions to avoid common pain points. Device types and challenges discussed will include:
- Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), Wearables, Mobile Medical Apps (MMA), Artificial Intelligence/Machine Learning (AI/ML) algorithms
- Risk Categorization for Software devices (FDA Level of Concern, IMDRF framework, EU, IEC 62304 )
- Artificial Intelligence (AI) machine learning and acceptability of predetermined change control plans (PCCP)
- Clinical evaluation (MDR) and performance evaluation (IVDR) challenges specific to software
- Cybersecurity implementation and alignment with ISO 14971 (Risk management)
- Aligning terminology and documentation across various requirements and processes (FDA Guidance Documents, AGILE, IEC 62304, QSR, MDR, IVDR)
- Off-the-shelf (OTS) and Software of Unknown Provenance (SOUP) expectations for documentation and V&V testing.
- Lack of information on connected devices

Learning Objectives:

  • Articulate common deficiencies in FDA and EU regulatory submissions.
  • Apply regulatory expectations and best practices in generation of software related documentation for regulatory submission.
  • Improve speed to market for US/EU software devices, avoiding mistakes that lengthen approval process, as well as identify challenges specific to EU/US submissions requiring changes from one region to another.