The purpose of this guidance is to identify the types of decision support software functionalities that: (1) do not meet the definition of a device as amended by the Cures Act; (2) may meet the definition of a device but for which FDA does not intend to enforce compliance with applicable requirements of the FD&C Act, including, but not limited to, premarket clearance and premarket approval requirements; and (3) FDA intends to focus its regulatory oversight on.
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- FDA Guidance for Drug Development