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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 September 2019

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions from the definition of device in section 201(h) of the FD&C Act. This guidance provides FDA's current thinking regarding the amended device definition and the resulting effect the amended definition has on FDA's guidances related to medical device software. The concepts detailed in this guidance are also reflected in the following guidance documents through Level 2 updates1:

The following guidance document has been withdrawn, for the reasons described in Section IV.D:

  • Guidance for the Submission of Premarket Notifications for Medical Image Management Devices

1 A Level 2 guidance document sets forth "existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1" (21 CFR 10.115(c)(2)). Because this final guidance sets forth the initial interpretations of FDA's statutory and regulatory requirements relating to software functions, it is a Level 1 guidance (21 CFR 10.115(c)(1)). FDA is making Level 2 updates to the listed guidance documents to make them consistent with existing practices as expressed in this final guidance.

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-6294.

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