Monthly Archives: May 2017

Third party review of 510(k) submissions – When it makes sense and which third party to choose?

fdaecopy/ May 24, 2017/ Third Party Review/ 0 comments

This article analyzes the data for third party review of 510(k) submissions to explain why only 2.5% of 510(k) submissions are reviewed by third parties. How many 510(k) submissions use a third party review? In 2016, I did an analysis of 510(k) submissions reviewed by the general and plastic surgery panel. I reviewed submissions that received clearance between January 1,

Read More

Reprocessed Single-Use Devices: Optimizing your efforts for 510(k) preparation

Mary Vater/ May 17, 2017/ Reprocessed Single-Use Devices/ 1 comments

This article explains the challenges reprocessors face in obtaining 510(k) clearance for reprocessed single-use devices when they are not the OEM. With increasing pressures on the medical device industry to make healthcare more affordable, there has been a push to reprocess and reuse single-use devices. Reprocessors obtain used devices from healthcare facilities. The reprocessors clean, process, resterilize, repackage, and relabel

Read More