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GUIDANCE DOCUMENT

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act 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Not for implementation.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This guidance is being distributed for comment purposes only.

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

Docket Number:
FDA-2017-D-6294
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance details the changes to existing guidance documents that relate to the regulation of the software functions described in section 520(o)(1)(A)-(D) of the FD&C Act. These sections describe software functions that do not meet the device definition in 201(h) of the FD&C Act. Section 3060 also describes limited circumstances when software functions described in 520(o)(1)(A)-(D) would remain devices.


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:

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-6294.