Question
Does anyone have examples of investigations about medical device recalls that they could share that was something upper management actually LIKED? I swear this is about the most political aspect of the medical device industry I've found and I really ...
Ooh, I've got a good one for you today: An FDA regulator is giving a special 90-minute webinar for Greenlight Guru and the Medical Devices Group. Shout out to Jon Speer for arranging. Your free registration at https://medgroup.biz/case-quality. Franc...
New FDA data continues to show an industry in crisis. One third (1/3) of all site inspections still get CAPAs that are voluntary or official actions. This holds true going back to 2009. See the chart below. Note the black line that holds steady as th...
The release of the FY 2018 FDA user fee schedule was delayed until the end of August, because the re-authorization of user fees was not approved until August 18, 2017. For PMA submissions and related supplements there is a 33% increase. For 510(k) su...
Veteran device CEO Joseph Gulfo says, "The FDA must be challenged (when appropriate) because it operates in a highly political environment and has strayed from its original mandate." His full 2016 10x Medical Device Conference talk, slides, and trans...
The FDA actually reduced their fees this year, effective October 1, but the FDA offers fee reductions for small businesses too. Most of my clients qualify, but very few of these small businesses take advantage of the FDA fee reduction. Small business...
FDA's New Biocompatibility Guidance is here. It's a detailed, lengthy guidance, with a strong emphasis on risk management grounded in a thorough knowledge of device materials toxicology. This is a very different guidance from the old G95-1. FDA Bioco...
As originally asked by
As originally shared by Julie Omohundro Principal Consultant at Class Three, LLC Thanks, Ginger. I've been thinking that if these devices pose low enough risk to support market entry based on certification alone, they pose low enough risk that they w...
UDI regulations kick in for Class I and II devices in 2015. So let's start the year with a free webinar for ways to make your UDI submissions easier. http://medgroup.biz/UDI-in-2015 Reed Tech is my go-to on this subject. They'll cover: • Requirements...
