Medical device emerging from a wave of innovation within a regulatory framework.

Navigating the 21st Century Cures Act: A Guide to Medical Device Regulation

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Nico Varela in Health & Wellness September 2025 • 5 min read.

"Is the Cures Act a departure from safety principles or a wave of innovation?"


The 21st Century Cures Act, enacted in late 2016, was designed to accelerate the discovery, development, and delivery of new technologies and pharmaceutical products. A key strategy involved modifying the pre-market approval processes of the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). This was intended to expedite the progress of new medical devices and other pharmaceutical products to market.

A significant part of the Cures Act focuses on streamlining Medicare coverage determinations for medical devices, aiming to facilitate their market access with reasonable payment terms. This intersection of FDA approval and Medicare coverage highlights the balance between fostering innovation and ensuring that new treatments are accessible to all who need them.

The regulation of medical devices brings to the forefront the tension between product safety and efficacy, the need for quick access to potentially life-saving devices, and the avoidance of unnecessary healthcare costs. Medicare coverage policymaking has become a crucial battleground where the costs of new medical technologies are debated. The central question is whether these new processes adequately protect the public from ineffective or unsafe products, and whether existing regulations can limit the use of expensive medical products that lack proven benefits.

Key Provisions of the Cures Act for Medical Devices

Medical device emerging from a wave of innovation within a regulatory framework.

The Cures Act introduces several provisions aimed at accelerating the approval and availability of medical devices. These provisions reflect a broader effort to balance regulatory rigor with the need for timely access to innovative healthcare solutions.

Here are some of the critical sections of the Cures Act impacting medical device regulation:

  • Section 3051: Breakthrough Devices: Grants the Secretary the authority to expedite the development and review of devices representing breakthrough technologies. These devices must offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions and lack approved alternatives.
  • Section 3052: Humanitarian Device Exemption: Increases the number of humanitarian device exemptions and directs the FDA to define criteria for establishing "probable benefit." This provision allows the humanitarian device exemption to apply to devices treating conditions affecting up to 8,000 individuals, up from the previous cap of 4,000.
  • Section 3053: Recognition of Standards: Establishes a clear process for the FDA to recognize standards set by national or international standards organizations, streamlining the review process. Device manufacturers can use third-party organizations to assess safety and effectiveness, reducing the need for direct FDA submissions.
  • Section 3054: Certain Class I and Class II Devices: Requires the Secretary to identify, within a set timeframe, any Class I devices that no longer require a report under subsection (k) to ensure safety and effectiveness.
  • Section 3055: Classification Panels: Improves the medical device classification panel review process by ensuring adequate expertise among panel members. It also allows device sponsors, patients, and representatives to recommend panel members and meet with the panel to address concerns and provide clarifying information.
  • Section 3056: Institutional Review Board Flexibility: Eliminates the requirement for medical device trials to always use a local institutional review board, allowing for centralized models.
  • Section 3058: Least Burdensome Device Review: Mandates an audit by the FDA ombudsman to assess measurements used to track the implementation of the least burdensome requirements. It clarifies that FDA reviewers must consider the least burdensome means for demonstrating safety and effectiveness.
These provisions collectively aim to reduce the regulatory burden on medical device manufacturers, expedite the approval process for innovative devices, and enhance collaboration between industry stakeholders and regulatory bodies.

The Path Forward: Balancing Innovation and Integrity

The central question remains whether the changes introduced by the Cures Act strike the right balance between promoting innovation and safeguarding public health. While administrative reforms aim to streamline processes, their effectiveness hinges on maintaining stringent regulatory standards and ensuring that all stakeholders act with integrity. The success of these reforms will depend on the character and commitment of regulators and industry participants to uphold the highest standards of safety and efficacy.

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Everything You Need To Know

1

What is the primary objective of the 21st Century Cures Act concerning medical devices?

The primary objective of the 21st Century Cures Act is to accelerate the discovery, development, and delivery of new technologies and pharmaceutical products, including medical devices. This is primarily achieved by modifying pre-market approval processes of the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) to expedite the availability of innovative healthcare solutions.

2

How does the Cures Act impact the Food and Drug Administration (FDA) approval process for medical devices?

The Cures Act significantly impacts the FDA approval process through several key provisions. Section 3051, for instance, grants the Secretary the authority to expedite the development and review of 'Breakthrough Devices.' Section 3053 streamlines the review process by enabling the FDA to recognize standards set by national or international standards organizations. Section 3058 mandates the FDA to consider the 'least burdensome' means for demonstrating safety and effectiveness. These measures collectively aim to reduce the regulatory burden and expedite device approval.

3

Explain the role of Medicare coverage determinations within the context of the Cures Act.

The Cures Act specifically addresses Medicare coverage determinations for medical devices to facilitate market access. The intersection of FDA approval and Medicare coverage is crucial because it influences the accessibility of new treatments to those who need them. Policymaking around Medicare coverage has become a focal point in debates about the cost and value of new medical technologies, highlighting the need to balance innovation with fiscal responsibility and patient access.

4

What are 'Breakthrough Devices' under Section 3051 of the Cures Act, and how does it affect their regulatory pathway?

Under Section 3051 of the Cures Act, 'Breakthrough Devices' are those that offer a more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions, and for which there are no approved alternatives. The Act grants the Secretary the authority to expedite the development and review of these devices. This fast-track approach aims to provide patients with quicker access to potentially life-saving technologies, recognizing the urgent need for innovation in areas where current treatments are insufficient.

5

How does the 21st Century Cures Act balance the need for innovation in medical devices with the imperative of ensuring patient safety and efficacy?

The 21st Century Cures Act attempts to balance innovation and safety through several strategies. While it aims to expedite device approval and streamline processes, it also emphasizes the importance of maintaining stringent regulatory standards. Provisions like Section 3058 on 'Least Burdensome Device Review' and the focus on 'Breakthrough Devices' are designed to foster innovation without compromising patient safety. Furthermore, the Act stresses the role of integrity among regulators and industry participants to uphold the highest standards of safety and efficacy. The success of the Cures Act hinges on this balance, which requires constant vigilance and adaptation by all stakeholders.

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