Question
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
June 2018
FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’New updates to the FDA's Software Pre-Cert working model shows the program is making significant gains, but FDA attorney Bradley Merrill Thompson tells FierceHealthcare the age...
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...
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 ...
Did you know 77% of the cost to develop a 510(k) device is spent in clinical research and regulatory submissions? It's 80% for PMA devices. "A lot of that cost is due to how poorly we handle data," explained Jim Rogers, President of Nextrials, at the...
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...
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...
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...
This is one of my better posts. You'll want to bookmark and share it. And you'll want to watch http://medgroup.biz/substantial, a 19-minute compilation from 2014's 10x Medical Device Conference. It features Ed Black, Tom KraMer, Pat Kullmann, Doug Li...
