Final FDA 510(k) Substantial Equivalence Guidance

FDA issued a final guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” dated July 28.2014. This guidance mentions software 18 times (including in the example). Software is considered one of the technological characteristics that could affect equivalence and examples include changes in the way software is used to analyze a patient’s anatomy or physiology.. The guidance also discusses the software information to be provided in the 510(k) related to demonstating substantial equivalence. The full guidance is at the link provided.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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