FDA 510(k) Submission Process Timeline/Overview

The FDA page at the link provided provides an overview of the 510(k) review process and timeline. It describes the acknowlegment procedure, Acceptance Review, Substantive Review, Interactive Review, AI Request and Decision Letter. It also provides a timeline and indicates all timeframes are in calendar days. Full Manual Link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

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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