Question
source: https://www.linkedin.com/groups/2070960/2070960-6200379152344846338
Surgeon's Criticism of FDA Echoed in Senator's Book It's the situation we all dread: A device with an obvious market and strong evidence of effectiveness bogs down in a seemingly endless FDA approval process. According to Colorado surgeon Dr. Robert ...
Group member Roger Cepeda wrote an informative (and cleverly worded) piece at https://medgroup.biz/RWE called "FDA’s Guidance on Real-World Evidence for Medical Devices: Great for Class III Registry Participants, But What About the Rest of MedTech?" ...
FDA Software Validations Are Tied to Manufacturer’s Implementation | iBASEtA very common misunderstanding of this validation requirement is that FDA compliance can be met by having their software vendors “validate” the software they are selling.sourc...
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...
Recently some of my clients received 483 observations for supplier controls and MDR reporting, but one of my clients asked which areas are FDA inspectors emphasizing. I noticed no significant changes, but I thought it was worth revisiting my Pareto A...
19 months ago we featured group member Mark DuVal's Citizen Petition and Petition for Stay of Action with the FDA. Read that discussion: http://bit.ly/FDA_petition The petition challenged FDA's practices and interpretations for reviewing 510(k)s and ...
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...
"Cybersecurity isn’t just a design issue. It’s not just at product launch. It’s a life cycle issue. It requires a change in mindset." So said FDA’s Suzanne Schwartz, MD, MBA, the Director of Emergency Preparedness/Operations and Medical Countermeasur...
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
September 2015
In this paper, I outline in detail the structural biases against anything new in the medical technology realm, including novel software. I wholeheartedly support FDA regulation of risky technology, but the law places disproportionately large regulato...
