Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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This draft guidance details the changes to existing guidance documents that relate to the regulation of the software functions described in section 520(o)(1)(A)-(D) of the FD&C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.
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.