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.

 

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just 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, TX) and Canada.