FDA Revised 510(k) Refuse to Accept Policy

FDA has a fully revised guidance “Refuse to Accept Policy for 510(k)s” dated Dec. 31, 2012. This includes a series of checklists including determining if the device is subject to 510(k), referring to all elements of the software submission guidance, and allowing for alternative approaches to information provided along with justification for the alternatives.


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

Email office@softwarecpr.com
for more info!

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