Question
FDA detractors have long complained it's faster and easier to earn a Conformité Européen (CE) mark versus FDA clearance. Is that about to change? Maybe, in light of revised text for new regulations proposed by the European Commission. You can partial...
As you know, medical devices sold in America require FDA clearance.Is gaining FDA clearance more stringent than obtaining a CE mark? And a question for regulatory experts in our group: Is it defensible for your sales reps to say to a prospect, "Well,...
Medical devices companies use modelling and simulation in the design phase but it's now possible in principle to produce evidences of safety and/or efficacy using computer models, something called In Silico Trials.FDA has produced guidelines, and the...
FDA has an agreement with EPA where low-level disinfectants used in areas like hospital rooms are regulated by EPA. A client has a low-level EPA-approved disinfectant cleared to inhibit microbial growth on the surface to which it is applied. But rece...
I use a FDA and CE registered sub-contract manufacturer for a FDA and CE registered Class 2a hand-held device., which my company sells around the world (in small numbers). We have implemented the UDI requirements. All fine. The issue comes when the m...
A single-member LLC with a non-US alien owner wants to sell Class I, 510(k)-exempt medical device via Amazon FBA. The manufacturer of the device is a foreign business entity and has a valid FDA registration. The LLC wants to sell the medical device a...
Is there any specific time line to update the labels including the UDI/human readable requirements for the *Class* *I* and *Ir* devices.
I frustrated regulatory expert Michelle Lott because, despite us having discussed it many times, I still couldn't grasp how draft documentation can screw up FDA submissions. Bless her Southern heart, she persevered. We recorded the call and you can u...
Article link below, quick summary of article: Why the regulation was needed, the changes and impacts, NB designations and Brexit updates, and steps to implement this huge change. See: EU MDR 2017/745 – Are You Ready for Big Changes?
I stumbled upon a significant idea with regulatory and quality expert Michelle Lott last week. Seize it immediately! Here's that 9-minute conversation. Get or renew your CE mark TODAY! If you prefer reading, the conversation highlights are: Get or re...
