SOFTWARE AS A MEDICAL DEVICE (SAMD): CLINICAL EVALUATION- NEW GUIDANCE FROM FDA AND GLOBAL REGULATORS

The FDA recently released a draft guidance entitled “Software as a Medical Device (SaMD): Clinical Evaluation”, which provides manufacturers with a proposed common methodology for clinical evaluation of standalone software regulated as a medical device. The document provides recommendations for continuous processes to evaluate these unique products as they operate “in a complex highly connected-interactive socio-technical environment in which frequent changes and modifications can be implemented more quickly and efficiently”. The guidance is closely aligned with EU standards for SaMD and is significant as it is the first time FDA has a taken a software-related document developed by the International Medical Device Regulators Forum (IMDRF) and issued it (in draft) as their own. However, the document was issued in draft form and is currently open for public comment, offering the potential for changes prior to final release. This webinar will address:

• Examining the guidance within the context of other FDA and international software regulations and guidance
• Guidance definitions, expectations and applications for clinical evaluation
  • Purpose of clinical evaluation
  • Types of evidence: Scientific validity , Analytical validity, Clinical performance
  • Categories of devices and associated level of evidence
• Identifying areas of ambiguity within the guidance that require refinement

Speakers:
Yarmela Pavlovic
Partner
Hogan Lovells

Kristin Zielinski Duggan
Senior Associate
Hogan Lovells