Blog Healthcare Manufacturing Specialization 
FDA Law
APRIL 25, 2023
Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” We have recently blogged on this topic (“ Is my software a medical device? ”). Special 510(k)s.
FDA Law
OCTOBER 6, 2023
There is much to unpack, and we intend to do so in a series of blog posts. The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Future blog posts will analyze FDA’s legal authority as well as FDA’s claimed public health need for LDT regulation.
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