Illustration depicting the 21st Century Cures Act and its impact on medical devices and patient safety.

The 21st Century Cures Act: Revolutionizing Medical Devices or a Risky Gamble?

Jordan Keane in Health & Wellness December 2025 • 4 min read.

"Unpacking the Controversial Law and Its Impact on Healthcare, Patient Safety, and Innovation"

In late 2016, a landmark piece of legislation, the 21st Century Cures Act, was signed into law with the ambitious goal of accelerating medical innovation. Proponents heralded it as a game-changer, promising faster access to cutting-edge medical devices and treatments. But beneath the surface of this promise lies a complex and often contentious debate. This article provides an in-depth analysis of the 21st Century Cures Act, exploring its core provisions, potential benefits, and the significant concerns it raises.

The primary focus of the Cures Act is to streamline the approval process for new medical devices and pharmaceuticals, aiming to expedite their journey to the market. This has led to significant changes in how the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) operate. While the intention is to speed up the delivery of life-saving treatments, critics question whether these changes adequately protect patient safety and ensure the efficacy of new medical technologies.

This analysis will delve into the key provisions of the Cures Act related to medical devices, dissecting the arguments for and against its implementation. We will examine the potential for innovation, the concerns of patient safety, and the broader implications for the healthcare system. By understanding the complexities of this legislation, we can better assess whether it truly represents a cure or a gamble with the future of healthcare.

Key Provisions of the 21st Century Cures Act and Their Potential Impact

Illustration depicting the 21st Century Cures Act and its impact on medical devices and patient safety.

The Cures Act introduces several key provisions designed to reshape the landscape of medical device regulation. These changes aim to expedite the review process, reduce regulatory burdens, and encourage innovation. However, each provision carries potential implications that warrant careful consideration.

One of the most significant changes involves the creation of a "Breakthrough Devices" program. This program is designed to fast-track the review of medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. While this could lead to quicker access to innovative technologies, it also raises concerns about whether the accelerated review process will compromise the thoroughness of safety and efficacy evaluations.

Breakthrough Devices: Expedited review for innovative devices, raising questions about review rigor.
Humanitarian Device Exemption: Increased access for devices treating rare conditions, but potential for limited evidence.
Recognition of Standards: Allows manufacturers to use third-party assessments, potentially streamlining approvals.
Changes to Classification Panels: Greater involvement for device sponsors, raising conflict-of-interest concerns.

The Act also addresses humanitarian device exemptions and the recognition of standards. Provisions for certain Class I and Class II devices, as well as improvements to the medical device classification panels. These changes have the potential to make the system more efficient, but also introduce new challenges.

Conclusion: Balancing Innovation and Patient Safety in the Era of the 21st Century Cures Act

The 21st Century Cures Act represents a bold attempt to accelerate medical innovation and improve patient access to life-saving technologies. However, the law's implementation has sparked considerable debate and concern. Striking the right balance between expediting approvals and ensuring patient safety is crucial. As the healthcare landscape evolves, it's essential to continuously evaluate the impact of the Cures Act, ensuring that it delivers on its promise of advancing medical breakthroughs while safeguarding the well-being of patients.

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Everything You Need To Know

What is the main goal of the 21st Century Cures Act, and what are some concerns associated with it?

The 21st Century Cures Act aims to accelerate medical innovation by streamlining the approval process for new medical devices and pharmaceuticals. While proponents say this will provide faster access to treatments, there are concerns that the expedited review process may compromise patient safety and the thorough evaluation of new medical technologies. It is believed that innovation and patient safety must find a balance.

How does the "Breakthrough Devices" program, established by the 21st Century Cures Act, intend to speed up the availability of innovative medical devices, and what are the potential drawbacks?

The "Breakthrough Devices" program aims to fast-track the review of medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. This expedited review could lead to quicker access to innovative technologies. However, there are concerns that the accelerated review process may compromise the thoroughness of safety and efficacy evaluations, potentially putting patients at risk if devices are not adequately tested. These devices might not be as safe or effective as originally thought.

Besides the "Breakthrough Devices" program, what other key provisions in the 21st Century Cures Act are designed to reshape medical device regulation?

Besides the "Breakthrough Devices" program, the 21st Century Cures Act includes provisions for humanitarian device exemptions, which increase access for devices treating rare conditions, and the recognition of standards, allowing manufacturers to use third-party assessments. The Act also implements changes to the classification panels, with greater involvement for device sponsors. While these changes may streamline approvals, they raise concerns about limited evidence for devices used in rare conditions and potential conflicts of interest in the device classification process.

What is the potential impact of allowing manufacturers to use third-party assessments for medical devices under the 21st Century Cures Act?

The 21st Century Cures Act's recognition of standards allows manufacturers to use third-party assessments, potentially streamlining the approval process for medical devices. While this could make the system more efficient and reduce regulatory burdens, there are concerns about the consistency and rigor of these third-party assessments. If the assessments are not as thorough or impartial as those conducted by regulatory agencies, it could lead to the approval of devices that are not safe or effective, and may have unforeseen consequences.

What steps are necessary to ensure the 21st Century Cures Act achieves its goal of advancing medical breakthroughs without compromising patient well-being?

To ensure that the 21st Century Cures Act balances innovation and patient safety, it's crucial to continuously evaluate the impact of the Act's provisions. This includes closely monitoring the effectiveness of the "Breakthrough Devices" program, ensuring the rigor of third-party assessments, and addressing potential conflicts of interest in the device classification process. Regular assessments and adjustments to the Act's implementation are necessary to safeguard patient well-being while still promoting medical innovation.