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 in Health & Wellness December 2025 • 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?

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.

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.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

Everything You Need To Know

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.

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.

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.

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.

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.