Canada Posts “Medical Device Data System” Rule
Any software that receives and manipulates patient data is a medical device.
Any software that receives and manipulates patient data is a medical device.
One should not mistake past regulatory discretion for lackadaisical enformcement on the part of the FDA.
What are your risks in being part of a regulated device, and what can you do to make yourself a more attractive supplier?
It is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.
Besides the obvious question of whether the FDA is really serious about regulating MDDS, a few things jump out as areas that need clarification.