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

蒋千琴 11/24/2021 浏览 244 FDA U.S

标准简介

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act[附网盘链接]是于不久前发布的FDA标准，适用于U.S。

标准截图

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act[附网盘链接]
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act[附网盘链接](截图)

 

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标准部分原文

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 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction 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 1

through Level 2 updates:

2

· General Wellness: Policy for Low Risk Devices

3

· Mobile Medical Applications

4

· Off-The-Shelf Software Use in Medical 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. 2

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-

low-risk-devices. 3

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-

functions-and-mobile-medical-applications. 4

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-

medical-devices.

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