FDA 510(k) Transfer Draft Guidance.

FDA issued a draft guidance Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers” dated Dec. 22, 2014. This guidance explicitly states that when a device is sold or transferred to another party FDA does not expect submission of a new 510(k). Now that 510(k) numbers are included in Device listings and required to be updated information FDA will now use this information to indicate the current holder of the device 510(k) and can be updated by manufacturers as needed and if needed outside the annual filing no additional fee is required.

It also states: “Because contract manufacturers and sterilizers, foreign exporters, and foreign private label distributors are not responsible for the commercial distribution of devices, they would not be 510(k) holders, and should list the product under their customer?s 510(k) number once it has been listed by the 510(k) holder.”

If more than one entity claims the same 510(k) within the same annual update period the most recent update is used by the database. FDA will contact the parties to determine the rightful owner.

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!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.