Question
Hello my esteemed colleagues!! I am attempting to learn as much as possible about the United States regulations and codes specifically regarding Medical Devices. I have a full list of predicate devices that I can prove do similar things to our device...
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...
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...
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...
A client of mine recently received a FDA Form 483 with multiple inspection observations and they wanted to know how to prioritize their corrective actions. Typically companies will work on corrective actions for each 483 observation in parallel. Howe...
Former $MELA CEO Dr. Joseph Gulfo's book "Innovation Breakdown" is so enlightening (and well-written) that I invited him to join the 10x faculty in May. Was his experience extreme, biased, or common? BACKGROUND • Each year, 150,000+ Americans are dia...
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
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...
*This is not professional advice.* In fact, it's borderline irresponsible, but here goes. So I was talking to this guy who found me from the group. To protect his anonymity, I'll be vague about his selling proposition. He told me he's building an app...
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...
