Futuristic medical device emerging from a complex regulatory network.

Navigating the Future of Medical Devices: How the 21st Century Cures Act is Reshaping Healthcare

Nico Varela monogram
Nico Varela in Health & Wellness November 2026 • 4 min read.

"A look into how regulatory shifts and a focus on streamlined processes are impacting the safety, efficacy, and accessibility of cutting-edge medical technologies."


In 2016, the 21st Century Cures Act was signed into law, heralding a new era for medical technology and pharmaceutical products. The core aim of the Cures Act was simple: to accelerate the journey of these innovations from the lab to the patient's bedside. This was to be achieved by streamlining the often-cumbersome pre-market approval processes managed by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS).

While the Cures Act touches upon various aspects of healthcare, its impact on medical devices is particularly noteworthy. The approval of these devices highlights the delicate balance between fostering innovation and ensuring patient safety. Expensive treatment options are set against the need for accessible healthcare, while the desire for rapid approval is weighed against the need for thorough safety and efficacy testing.

Medicare coverage policy has long been the arena where discussions about healthcare costs come to the forefront. A powerful medical supply industry constantly seeks to introduce new technologies, while regulators and healthcare professionals remain vigilant about safety, efficacy, and cost-effectiveness. This article dives into the key questions: How do these new processes affect the quality and accessibility of medical devices? Are existing safeguards sufficient to protect the public? And are we truly balancing innovation with responsible healthcare?

AI Search Multiple angles on this topic

Accelerating Access While Preserving Safety

Signed into law on December 13, 2016, the 21st Century Cures Act was designed to accelerate medical product development and bring innovations to patients more quickly. Its medical-device provisions reflect a continuing tension between assuring product safety and efficacy and making devices available without unnecessary costs or delays. Critics argue that Title III can promote evidentiary shortcuts that weaken the FDA approval process's safety and efficacy standards. The debate therefore centers on whether faster access can be achieved without compromising patient protection.

A Regulatory Milestone in 2016

The FDA's historical chronology identifies major milestones in the development of medical-device legislation and oversight in the United States. One important milestone occurred in 2016, when the 21st Century Cures Act made it easier for new devices to be approved. The Act expanded the FDA's expedited review policy, increased use of least-burdensome reviews, and made it easier for devices to receive 510(k) exemption. It also increased the population threshold for Humanitarian Device designation from 4,000 to 8,000 and altered internal review procedures.

The Cures Act: Streamlining or Compromising Medical Device Safety?

Futuristic medical device emerging from a complex regulatory network.

Modern pharmaceutical regulation began in the 1930s after a tragic incident involving a poisonous solvent in a new medicine led to numerous deaths. This event spurred the creation of the Food, Drug, and Cosmetic Act (FDCA), setting standards for drug safety and approval. Similarly, the thalidomide crisis in the 1960s, where a drug caused severe birth defects, further strengthened the FDA's regulatory oversight.

The AIDS epidemic in the 1980s once again shifted the landscape. With patients desperately needing new treatments, the FDA faced pressure to expedite approvals. This led to the Food and Drug Administration Modernization Act of 1997 (FDAMA), aimed at faster approval of AIDS remedies and other promising therapies. FDAMA also emphasized clear communication, requiring the FDA to make its guidance practices more accessible to the public.

  • Expediting Breakthrough Devices: Section 3051 prioritizes the development and review of devices representing breakthrough technologies, offering more efficient and flexible approaches.
  • Expanding Humanitarian Device Exemptions: Section 3052 increases the number of humanitarian device exemptions, encouraging development of devices for rare conditions.
  • Recognizing Standards: Section 3053 establishes a clear process for the FDA to recognize standards set by national and international organizations, streamlining the review process.
  • Involving Device Sponsors: Section 3055 ensures greater involvement of device sponsors, patients, and representatives in the device classification panel review process.
AI Search Multiple angles on this topic

Regulatory Evolution and Emerging Technologies

A March 1, 2024 review of the medical-device development ecosystem reports that FDA guidance on early feasibility studies has helped address impediments to early-stage device studies in the United States. The review also describes the 21st Century Cures Act as holding promise for improving Americans' health status. Cures 2.0, introduced in 2021, built on the original Act's successes, while major components became policy, including the establishment of the Advanced Research Projects Agency for Health. Separately, the Cures Act clarified that certain software functions, including specified administrative functions, fall outside the Federal Food, Drug, and Cosmetic Act's device definition.

Transparency and Regulatory Tradeoffs

The FDA generally cannot publicly disclose whether a sponsor has submitted a Breakthrough Device designation request or whether the request was granted or denied before marketing authorization, unless the sponsor chooses to make that information public. Critics of the medical-device regulatory scheme identify problems that can affect both FDA resources and the balance between manufacturers and the public. The debate over the 21st Century Cures Act likewise focuses on whether faster innovation creates risks for patients, manufacturers, and the healthcare system. These concerns have made transparency, oversight, and accountability central to criticism of the Act's implementation.

However, some experts are concerned that these changes could weaken regulatory oversight. As Jerry Avorn and Aaron Kesselheim pointed out, the Cures Act might redefine the evidence needed for high-risk device approvals, potentially relying on less rigorous data like case studies instead of clinical trials.

The Path Forward: Balancing Innovation and Integrity

The 21st Century Cures Act has undoubtedly sparked progress in medical device regulation. However, whether these changes ultimately benefit patients and the healthcare system depends on a crucial ingredient: integrity. This means ensuring that regulators and industry stakeholders act ethically, prioritize patient safety, and maintain transparency throughout the approval process. Only then can we hope to harness the full potential of medical innovation while safeguarding public health.

AI Search Multiple angles on this topic

Redrawing the Software Boundary

Section 3060 of the 21st Century Cures Act, known as the software provisions, changed where the FDA draws the boundary of what counts as a medical device. The Act excludes certain categories of clinical software from FDA device regulation, including clinical decision-support tools that meet four specific criteria. The Congressional Research Service similarly reports that the Act clarified the scope of software functions covered by the device definition. This creates an ongoing policy question about how to balance innovation in clinical decision support with appropriate oversight.

The 2026 MedTech Policy Horizon

A March 4, 2026 analysis reports that the 21st Century Cures Act 2.0 is expected to affect MedTech startups by 2026. The projected regulatory shifts focus on data sharing, interoperability, and digital-health innovation. The analysis indicates that startups will need to adapt strategically to these changes in order to grow. These areas represent the next regulatory frontier identified by the source.

Evidence From Real-World Use

In spring 2020, the Office of the National Coordinator for Health Information Technology introduced regulations covering the 21st Century Cures Act's interoperability and information-blocking requirements, along with the ONC Health IT Certification Program. These measures governed the API prerequisite while also establishing safeguards against information blocking. The Act has also supported FDA initiatives involving real-world evidence, including cases in which biopharmaceutical and medical-device companies used such evidence to pursue positive regulatory approval. For medical devices, real-world performance can vary with user expertise and clinical setting, and devices often undergo modifications over time.

What coverage and approval figures do-and do not-show

FDA authorization and Medicare coverage are separate milestones: the long interval to nominal coverage indicates that authorization alone did not mean coverage had already followed. The estimate is also uncertain at its upper end because relatively few technologies achieved coverage in the period examined.[1]

CMS approval of every breakthrough-device application in this small set is a result for those applications, not evidence that every breakthrough device receives supplemental payment. Short endpoint follow-up and reliance on surrogate measures also leave questions about how well the evidence captured effectiveness for Medicare beneficiaries.[2]

What remains unresolved in device evidence and oversight

  • When pivotal studies leave questions about follow-up, surrogate outcomes, primary endpoints, or whether enrolled patients resemble Medicare beneficiaries, how much can their results establish about effectiveness in the population receiving coverage?[2]
  • If postmarket surveillance is expected to reduce the premarket evidence burden, how can safety and effectiveness be established when FDA authority to require postmarket device studies is limited?[3]
  • How should the boundaries for excluded clinical decision-support software be applied as software functions evolve, given that FDA guidance describes which functions meet the statutory exclusion criteria?[4] [5]

Sources

  1. Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies (pmc.ncbi.nlm.nih.gov)
  2. Medical Devices Applying for Outpatient Medicare Supplemental Payments (pmc.ncbi.nlm.nih.gov)
  3. The 21st Century Cures Act (Division A of P.L. 114-255) - EveryCRSReport.com (www.everycrsreport.com)
  4. Clinical Decision Support Software | FDA (www.fda.gov)
  5. Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act | FDA (www.fda.gov)

About this Article -

Written with AI assistance from published research, and reviewed by the Mystum team. See our About page for more information.

Everything You Need To Know

1

What is the 21st Century Cures Act, and what does it aim to achieve in the context of medical devices and healthcare innovation?

The 21st Century Cures Act, enacted in 2016, aims to accelerate the development and approval of new medical technologies and pharmaceutical products. It seeks to streamline the regulatory processes of the FDA and CMS to bring innovations to patients faster. A critical focus of the Cures Act is on medical devices, balancing the promotion of innovation with ensuring patient safety and efficacy. The goal is to facilitate quicker access to cutting-edge medical devices while maintaining necessary safeguards. Medicare coverage policies and the influence of the medical supply industry also play significant roles in healthcare costs and the adoption of new technologies.

2

What is the Food, Drug, and Cosmetic Act (FDCA), and why was it initially created?

The Food, Drug, and Cosmetic Act (FDCA) was created in the 1930s, setting standards for drug safety and approval. It was a direct response to a tragedy involving a poisonous solvent in a new medicine that caused numerous deaths. This act was crucial because it established the foundation for pharmaceutical regulation in the United States, ensuring that drugs are safe and effective before they are made available to the public. Further strengthening of the regulatory oversight came after the thalidomide crisis in the 1960s, where a drug caused severe birth defects.

3

What is the Food and Drug Administration Modernization Act (FDAMA), and what circumstances led to its creation?

The Food and Drug Administration Modernization Act of 1997 (FDAMA) aimed to speed up the approval of AIDS remedies and other promising therapies during the AIDS epidemic in the 1980s. The FDA faced immense pressure to expedite approvals due to the urgent need for new treatments. FDAMA emphasized clear communication and required the FDA to make its guidance practices more accessible to the public. This was significant because it balanced the need for faster approvals with the necessity of maintaining safety standards and transparency in the regulatory process.

4

What specific sections within the 21st Century Cures Act are designed to expedite the development and review of medical devices?

The 21st Century Cures Act includes several sections designed to expedite the development and review of medical devices. Section 3051 prioritizes breakthrough technologies, while Section 3052 increases humanitarian device exemptions for rare conditions. Section 3053 establishes a clear process for the FDA to recognize standards set by national and international organizations. Section 3055 ensures greater involvement of device sponsors and patients in the device classification panel review process. These changes are intended to streamline the regulatory process and encourage innovation.

5

What is needed to ensure the 21st Century Cures Act ultimately benefits patients and the healthcare system, and what concerns have been raised about its implementation?

To ensure the 21st Century Cures Act benefits patients and the healthcare system, integrity is essential. This means regulators and industry stakeholders must act ethically, prioritize patient safety, and maintain transparency throughout the approval process. Concerns exist that the Cures Act might lead to reliance on less rigorous data, like case studies instead of clinical trials, for high-risk device approvals. Upholding ethical standards, focusing on patient well-being, and ensuring transparency are critical to harnessing the full potential of medical innovation while safeguarding public health.

Newsletter Subscribe

Subscribe to get the latest articles and insights directly in your inbox.