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GUIDANCE DOCUMENT

Clinical and Patient Decision Support Software Guidance for Industry and Food and Drug Administration Staff December 2017

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2017-D-6569
Issued by:
Guidance Issuing Office
Center 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.


Submit Comments

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:

Dockets Management
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.