Clinical and Patient Decision Support Software
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
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 118requirements 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6569.