Refuse to Accept 510(k)

FDA issued a version of its “Refuse to Accept Policy for 510(k)s” dated 21-Feb-2019. This supersedes the prior 30-Jan-2018 version.  As FDA guidance goes, this a short period of time between updates.  It focuses on explaining the initial 15 day administrative completeness check, review initial questions, provision of a checklist for this administrative review which includes checking that if standards are referenced in any way their usage is explained, any device-specific guidance was addressed, electrical safety and EMC information is included if relevant.

The term Software is used many times in this guidance including that if software is included in the device the information requested in the FDA “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and the associated Off-the-shelf software guidance (if relevant) is included. If a device does not contain software it must be clearly indicated that it does not.

The full guidance is at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf

Read our earlier posts on this subject FDA Final Revised Refuse to Accept Policy (1/30/18) and FDA Revised 510(k) Refuse to Accept Policy (1/3/13)

 

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@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.