de novo process
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Get it written →You are a regulatory professional at a mid-size medical device company. Your company is developing a new medical device. You have started researching and found a medical device that isn’t the same but has similarities to your company’s new device. Would you advise management to file a de novo classification? Or would you recommend a different regulatory strategy? If so, what is your regulatory strategic advice?
write one primary response (1 primary)
and comment on others response (2 secondary responses)
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