Medical device innovation balanced with patient safety.

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

Elliot Brynn in Health & Wellness December 2025 • 4 min read.

"A closer look at how the Cures Act impacts medical device regulation, approval processes, and accessibility in the healthcare industry."

In December 2016, the 21st Century Cures Act was signed into law with the promise of speeding up the development and approval of new medical technologies and pharmaceutical products. This legislation was designed to "accelerate the discovery, development, and delivery of 21st-century cures," primarily through changes to the processes of the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS).

The Act has provisions intended to simplify Medicare coverage determinations for medical devices, aiming to facilitate quicker market access with reasonable payment structures. However, the balance between expediting access to innovative treatments and ensuring patient safety remains a critical point of discussion.

This article will explore the impact of the Cures Act on medical device regulation, examining whether it truly propels healthcare forward or introduces unacceptable risks. We'll delve into the perspectives of manufacturers, regulators, and healthcare professionals, and consider whether the Act's reforms strike the right balance between innovation and safety.

Key Provisions of the Cures Act Affecting Medical Devices

Medical device innovation balanced with patient safety.

The 21st Century Cures Act introduces several provisions designed to streamline the FDA's approval process for medical devices. These changes aim to reduce the time and cost associated with bringing new technologies to market.

Here are some of the key provisions:

Breakthrough Devices Program: Expedites the development and review of devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
Humanitarian Device Exemption (HDE): Expands the availability of HDEs, allowing devices for rare diseases or conditions affecting smaller populations to reach the market more easily.
Recognition of Standards: Streamlines the process for recognizing standards developed by national and international organizations, reducing the need for manufacturers to repeatedly demonstrate compliance.
Institutional Review Board (IRB) Flexibility: Allows for the use of centralized IRBs in multi-site clinical trials, potentially reducing administrative burdens and accelerating trial timelines.
Least Burdensome Device Review: Requires the FDA to consider the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness.

While these provisions are intended to foster innovation, they also raise concerns about the level of scrutiny applied during the approval process. Some experts worry that the emphasis on speed could lead to the approval of devices that are not as safe or effective as they could be.

Finding the Right Balance: Innovation vs. Safety

The 21st Century Cures Act represents a significant shift in the regulatory landscape for medical devices. While the goal of accelerating innovation is laudable, it's crucial to carefully monitor the impact of these changes on patient safety and device effectiveness. The integrity of the approval processes, the ethical conduct of regulators and manufacturers, and ongoing post-market surveillance will be essential to ensuring that new medical technologies truly benefit patients and improve healthcare outcomes. Only time will tell if the Cures Act will successfully navigate this complex terrain.

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Everything You Need To Know

What is the 21st Century Cures Act and what are its primary goals?

The 21st Century Cures Act, signed into law in December 2016, aims to expedite the development and approval of new medical technologies and pharmaceutical products. Its primary goals involve accelerating the discovery, development, and delivery of 21st-century cures. This is primarily achieved through changes to the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) processes.

How does the 21st Century Cures Act streamline the FDA's approval process for medical devices?

The Cures Act introduces several provisions to streamline the FDA's approval process for medical devices. These include the Breakthrough Devices Program, which expedites the review of devices for life-threatening conditions; the Humanitarian Device Exemption (HDE), which expands access for devices treating rare diseases; and the Recognition of Standards, which simplifies compliance. Additionally, the Act allows for Institutional Review Board (IRB) flexibility and mandates a Least Burdensome Device Review.

What are the potential risks associated with the provisions of the 21st Century Cures Act?

While the 21st Century Cures Act aims to foster innovation, there are concerns about the level of scrutiny applied during the approval process. Some experts worry that the emphasis on speed could potentially lead to the approval of devices that may not be as safe or effective as they could be. The balance between expediting access to innovative treatments and ensuring patient safety remains a critical point of discussion.

How does the Breakthrough Devices Program function within the framework of the 21st Century Cures Act?

The Breakthrough Devices Program, a key provision of the 21st Century Cures Act, is designed to expedite the development and review of medical devices. It specifically targets devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. This program aims to accelerate the availability of these critical technologies to patients by providing a more streamlined pathway through the FDA approval process, thus reducing the time and resources required to bring these devices to market.

What measures are crucial to ensure patient safety and device effectiveness following the implementation of the 21st Century Cures Act?

To ensure patient safety and device effectiveness after the implementation of the 21st Century Cures Act, several measures are crucial. These include maintaining the integrity of approval processes, ensuring ethical conduct among regulators and manufacturers, and conducting robust post-market surveillance. These efforts are essential to monitor the long-term performance and safety of medical devices, addressing any potential issues that may arise after the devices are in use. Only through these measures can the industry ensure that new medical technologies truly benefit patients and improve healthcare outcomes.