FDA Consultation on Development of 21st Century Cures Act Section 3060 Required Report: Request for Input
Updated: Jul 28
On 14 July 2026, the U.S. Food and Drug Administration (FDA) requested input to support its 2026 report on certain healthcare-related software functions that are excluded from the statutory definition of a medical device. FDA is seeking information on their impact on patient safety, associated health benefits and risks, and best practices relating to safety, education, and competency.
Overview
Authority | U.S. Food and Drug Administration (FDA) |
Date | 14 July 2026 |
Focus | Patient-safety impacts, health benefits and risks, and best practices associated with non-device software functions |
Type | Request for input for a statutory report |
Deadline for comments | 13 August 2026 |
What is this about?
Section 3060 of the 21st Century Cures Act amended the Federal Food, Drug, and Cosmetic Act to exclude certain software functions from the definition of a medical device. These exclusions are set out in section 520(o)(1)(A)–(E) of the FD&C Act.
They cover certain software functions intended for:
Administrative support of healthcare facilities
Maintaining or encouraging a healthy lifestyle
Serving as electronic patient records
Transferring, storing, converting formats, or displaying data
Providing limited clinical decision support
The Department of Health and Human Services (HHS) must report every two years on the health risks and benefits associated with these functions and summarize their impact on patient safety, including relevant best practices. FDA develops this report in consultation with other HHS agencies involved in health information technology and uses stakeholder input to inform its findings.
The current request is intended to gather evidence and stakeholder experience for the 2026 report. It is not a consultation on proposed changes to the statutory definition of a medical device or on new regulatory requirements for software.
Consultation details
FDA is seeking input on the impact of non-device software functions in three main areas:
Patient safety
Benefits and risks to health
Best practices to promote safety, education, and competency
Relevant submissions may include data, practical experience, safety findings, implementation experience, or other evidence concerning software functions covered by section 520(o)(1)(A)–(E) of the FD&C Act.
FDA will consider the submitted information when preparing the 2026 report required under section 3060(b) of the 21st Century Cures Act.
Key timeline
Deadline for comments: 13 August 2026
Why this matters
The request concerns software functions used in healthcare or health-related contexts that Congress has excluded from the medical-device definition when the statutory criteria are met.
Although FDA is not proposing new requirements, the report will provide Congress with updated information on the safety, benefits, risks, and appropriate safeguards associated with these functions. It may serve as an input to future policy discussions and oversight activities concerning non-device software functions.
Organizations with relevant evidence can help FDA distinguish between benefits, practical safety concerns, and effective risk-management measures across the different categories of software.
Engaging with the request may allow stakeholders to provide operational experience and technical evidence before FDA finalizes the 2026 report.
Who should consider responding?
Developers and vendors of health information technology
Developers of software functions relying on the exclusions in section 520(o)(1)(A)–(E)
Healthcare providers and healthcare organizations using these software functions
Health plans and other third-party payers with relevant experience
Patients, consumers, and patient representatives with evidence concerning safety or usability
Other stakeholders with relevant patient-safety, technical, or implementation expertise
Practical implications
Stakeholders should consider:
Determining whether they develop, supply, implement, or use software functions covered by section 520(o)(1)(A)–(E)
Identifying relevant evidence on patient-safety benefits, risks, incidents, or implementation challenges
Reviewing available information on training, user competency, usability, and risk controls
Preparing focused comments supported by data or documented practical experience
Support with stakeholder responses
We support organizations in:
Assessing whether regulatory consultations are relevant to their products, technologies, or business objectives
Identifying strategic risks, opportunities, and emerging regulatory trends
Preparing structured and evidence-based responses to authorities
Contact us if you would like to discuss how this request may affect your organization, software portfolio, or planned regulatory activities.
Note
Check back regularly for updates on ongoing consultations and emerging regulatory
trends.