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...
Medical devices and IVD regulatory expert with a global perspective
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...
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 ...
D. Michelle Williams
VP - Operations at Action Products, Inc.
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?" ...
"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...
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 ...
Ship & Print Your FDA eCopy
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...
Writer at iBASEt
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...
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
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...