Question
I am working with a start up, young energetic crowd, towards developing a new medical device. First version is off-the shelf monitor, not going for FDA approval. But later versions will aim for it. Nonetheless, it is to be used for monitoring infant ...
19 months ago we featured group member Mark DuVal's Citizen Petition and Petition for Stay of Action with the FDA. Read that discussion: The petition challenged FDA's practices and interpretations for reviewing 510(k)s and asked the Commissioner to s...
FDA issued "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" this week. Group member Glenda Guest included the link at and began a discussion about it. Among the changes are guidance on the appropriate use o...
I’ll be honest: I can’t even imagine what it’s like to learn my implant is being recalled. But that’s what happened to a group member who prefers anonymity for legal reasons. She writes: “I was appalled to receive a letter that my two-year-old hip re...
I work for a class II medical device manufacturer that has never done anytime of marketing. My job is to get us into the 21st century with aligning us with the way buyers want to educate themselves and buy - which is digital marketing strategies. How...
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