How Developers Can Benefit from the FDA’s Center for Devices and Radiological Health (CDRH) New Innovation Policies

The Center for Devices and Radiological Health (CDRH) recently released its 2024 innovation report. The CDRH is a department of the US Federal Drug and Administration (FDA). The CDRH promotes public health by ensuring that medical devices and radiation-emitting devices are safe. The department provides healthcare professionals, patients, and consumers with “understandable and accessible science-based information about the products the CDRH oversees.”

The CDRH states that America “is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety.”  Through post-market surveillance, devices that aren’t performing well can be quickly identified, properly assessed for how well the devices are performing, are legally marketed, are safe, and are of high quality.

In this article we discuss CDRH’s commitment to innovation so that the developers of medical devices can understand how the FDA can help their ideas become real products used in healthcare, and how doctors and patients can assess the quality of the medical devices that doctors prescribe and patients use.

The CDRH’s commitment to innovation

The FDA’s 2024 CDHR innovation report discusses how the CDRH is continually working to encourage the development of new and better medical devices for patient care in the United States. The CDRH states that in the past CDRH hasn’t encouraged the development of new medical devices as well as the CDRH should have. That focus started to change in 2009 when CDRH established new goals for medical device innovation combined with medical device safety.

Since 2009, the CDRH has increased its approval of medical devices and related products by 500%. This goal has been achieved with the help of numerous US customers.

The CDRH emphasizes that the department does not aim to act in competition with other countries. Rather the goal of the CDRH innovation policies is to “provide a metric for timely patient access to devices that meet the FDA’s standards.”

Encouraging Innovation

The CDHR states that the department is encouraging innovation in the following ways:

• Enhancing the FDA’s 510(k) and De Novo premarket review programs.
  • “A 510(k) is a premarket submission made to CDRH to demonstrate that the medical device to be marketed is substantially equivalent to a legally marketed device.”
  • “The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.”
• Implementing policies to help streamline the review process while also requiring that the developer seeking approval of a medical device provide more data to support FDA authorizations – “as medical technologies become more complex.”
• Creating and continuing the following programs to advance innovation
  • The Breakthrough Devices Program – and – Safer Technologies Program (STeP). This program helps “create access to life-saving devices by expediting regulatory review.” The program engages senior management, prioritizes review of certain devices, and encourages prompt communication. The Breakthrough Devices Program has led to the authorization of more than 100 medical devices since 2015. The Step program has led to the authorization of 2 medical devices since the program began in 2021.
  • The Safety and Performance-Based Pathway Program. This CDRH program helps to ensure the public has access to better quality medical devices by helping innovators/developers assess devices against certain performance guidance documents. The program “promotes the use of modern predicate devices” and ends the need to procure predicate devices. Since its creation, the CDRH has published 10 guidance documents.
  • The Digital Health Center of Excellence. This program fosters “responsible and high-quality digital health innovation.” The program reimagines the “medical device regulatory paradigm” so it’s a better fit for digital health technologies. Since its inception, 700 AI/ML (artificial intelligence/machine language)-enabled devices have been authorized.

Increasing Regulatory Flexibility

CDRH is increasing regulatory flexibility in several ways:

• Strengthening and streamlining the clinical trial enterprise (including by “significantly reducing the time to authorize well-designed clinical trials”)
• Establishing new feasibility policy studies
• Creating clinical trial networks
• Finding new ways to “collect real-world data and to use real-world evidence to support our marketing authorization decisions and post market monitoring capabilities.”

The CDRH:

• Reformed Clinical Trial Program encourages medical device developers to perform studies in America so patients can have faster access if the devices are approved. This program has reduced the “median time to clinical trial authorization by 90 percent.”
• Is using an “updated, flexible framework for Benefit-Risk Decision-Making” so that the framework aligns with reasonable regulatory assurance standards. 6 guidance documents have been issued.
• Is using real-world data and evidence (RWE) instead of conventional clinical trial data in an attempt to “reduce the time to answer device questions.” Since the CDRH began this approach more than 100 devices using RWE have been authorized. The CDRH states that this approach has also led to the “creation of a National Evaluation System for Health Technology (NEST).” The FDA, since this approach began has engaged with “100 national or regional registries from 45 countries.”

Partnering with Patients and Stakeholders

The CDRH states that the department has made working with patients, the ultimate users of the medical devices, part of the innovation process. The CDRH emphasizes customer service by “co-founding the Medical Device Innovation Consortium (MDIC)” to “advance the development of medical device regulatory science as well as establishing a qualification program for and developing a catalog of regulatory science tools.”

Some of the critical programs CDRH is using to help obtain more patient and stakeholder input include:

• The CDRH co-founded the International Medical Device Regulators Forum (IMDRF) to help provide worldwide access to medical devices.
• The CDRH works to include patient points of view in the Total Product Life Cycle Advisory Program (TAP) of medical devices.
• The CDRH has included more than half of its Patient-Reported Outcomes (PROs) in its clinical studies.
• “The use of peer-reviewed Regulatory Science Tools (RSTs) allows innovators to efficiently navigate the design and redesign loop, and expedite medical device innovation.”

The CDRH is also working with the International Medical Device Regulators Forum (IMDRF), a group of medical device regulators from around the world. Its “Collaborative Communities bring stakeholders together to address health care challenges.”

Collaborating with Innovators

The CDRH is also working with innovators to help make the CDRH’s regulatory programs more predictable, efficient, and effective. The CDRH started, and has now expanded, a pilot of our Total Product Life Cycle Advisory Program (TAP) to help achieve these goals. The CDRH aims to enroll 325 innovators by 2027.

Looking Forward

The CDRH aims to continue to improve its goal of more innovation in the following ways:

• Modernizing Premarket Review. This includes communicating clearly and reasonable expectations, “facilitating high-quality submissions and first-cycle authorizations,” and enabling prompt review and decision-making.
• Bringing FDA to Innovators.  The CDRH wants to co-locate TAP advisors in innovation, enable early conversations with the FDA, and use FDA expertise – all to help innovate, reduce costs, reduce risks, and save time.
• Launch Home as a Health Care Hub.  The CDRH wants to “focus prevention, wellness and health care on the person right where they live,” and take many other steps to create innovative medical devices that can be used in patient’s homes.

The CDRH states its efforts are working. America is becoming a more attractive place for the development of medical devices.

The developers of medical devices need help from experienced lawyers for many reasons including being able to navigate the FDA premarket and de Novo approval process. The CDRH is working to increase the approval rate for medical devices through a variety of programs that aim to help innovators and patients alike. Understanding the CDRH approval process and the department’s new policies can increase a developer’s chances for approval. Our skilled healthcare professionals understand the FDA approval process and how the CDRH can help you bring your medical device to market.

The developers of medical devices should contact Cohen Healthcare Law Group, PC to discuss their legal and healthcare compliance requirements. Our experienced healthcare attorneys advise medical businesses about healthcare compliance laws and regulations issues.