FDASIA Draft Health IT Regulatory Strategy

The FDA released its anticpated draft report on regulation of Health IT. This report includes a risk-based regulatory framework for health information technology (health IT) that is a step towards clarifying what software will be actively regulated by FDA. The report was developed by the U.S. Food and Drug Administration in coordination with the Health and Human Services Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC). The three categories of Health IT identified are: administrative health functions, health management functions, and medical device functions with the latter remaining actively regulated in a traditional manner by FDA. The FDA is seeking feedback on this approach and wil be schedulign a public meeting in May for this purpose. The full report is at the following link: Health IT Report.

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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