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