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Hi Steven, I was able to download it from the FDA website: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref= Hopefully, you'll be able to open it. Let me know and good luck! Carol ------------------------------ Carol ------------------------------

Thank you so much, Anne. It didn't cross my mind to check the IRS website - much appreciate your pointing me there. ------------------------------ Carol ------------------------------

Greetings everyone! I've been tasked with figuring out if our class II SaMD is FSA/HSA eligible. As I did some online digging, I came across this Guide to HSAs/FSAs for your Digital Health Product/Service, according to which, medical software and hardware devices can indeed be purchased with HSA/FSA ...

Hi Nancy, Some context for your question would be helpful.  •    Is the adversarial colleague in the same department?  •    Are they in a more senior position? •    What seems to 'trigger' adversarial behavior?  •    Is the target of the adversarial behavior the same person or does it appear to be ...