FDADraft 510(k) exemptions intent

FDA issued a Draft “Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements” guidance on August 1, 2014. This document is at the link provided. For device code LLN if software is used to analyze clinical implication fo a measurement a 510(k) will be required. Many other device types and intended uses are identified in this gudiance as being 510(k) exempt.

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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