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CDRH Statement: FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program

Sept 6, 2023

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH)

Today, the U.S. Food and Drug Administration issued three new draft guidances to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices. CDRH believes in the merits of the 510(k) Program and has taken steps over the past decade to assure it continues to meet the needs of patients, provides appropriate patient safeguards, and supports decision-making that is based on sound science.

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 three draft guidances seek to enhance the existing 510(k) Program by providing clarity on complex device topics in 510(k) submissions. CDRH is continually working to optimize our tools to help ensure patients have timely access to safe, effective, and high-quality medical devices.

Issuing these draft guidances marks an important step in our ongoing commitment to optimize the clarity, predictability, and consistency of the 510(k) Program as CDRH implements MDUFA V.

Key Efforts Aimed at Modernizing the 510(k) Program

Over the past 10 years, CDRH has continually worked to strengthen and modernize the 510(k) Program starting with an evaluation and set of recommendations for improvements. We describe several steps we implemented in a November 2018 performance report. As a result, in part of CDRH's actions, including the development of policies to clarify the FDA's expectations for the content of 510(k) submissions, the average page count of a 510(k) submission has more than doubled, to over 1,000 pages, since 2009, reflecting the growing complexity of devices. In light of this increasing technological complexity, clinical data are increasingly necessary in a 510(k) submission to support substantial equivalence.

Released in April 2018, the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health outlines a vision for how CDRH can continue enhancing the FDA's programs and processes to assure the safety of medical devices throughout the total product life cycle (TPLC). The goal is to provide for timely identification, communication, and resolution of new or increased known safety issues, and to advance innovative technologies that are safer, more effective, and address unmet needs. This plan aims to spur innovation toward safer medical devices and advance the use of a TPLC approach, among other goals.

In September 2019, CDRH finalized guidance on the Safety and Performance Based Pathway, an alternative to the Traditional 510(k) Program. This pathway provides for manufacturers of certain, well understood device types to demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device. This new, efficient pathway may provide for manufacturers to demonstrate that their device meets or exceeds modern performance criteria to support 510(k) clearance, as well as incentivize the development of safer, more effective devices by demonstrating their product's superior performance to existing devices more readily. Since the issuance of the Safety and Performance Based Pathway final guidance, we have published ten device-specific final guidances for devices with corresponding FDA-identified performance criteria ranging from bone screws to magnetic resonance coils.

In November 2018, CDRH proposed transformative new steps to modernize the 510(k) Program to advance the review of the safety and effectiveness of medical devices. In January 2019, CDRH requested public feedback on these steps (also, see docket FDA-2018-N-4751 "Modernizing FDA's 510(k) Program; Establishment of a Public Docket; Request for Comments") to continue to modernize the framework for 510(k) review while promoting patient safety and posed other questions that could inform regulatory policy development.

One option for modernizing the FDA's 510(k) Program included in the FDA's proposal was to make public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices (greater than 10 years old). Several comments pointed out that focusing only on older predicates may not optimally promote safer and more effective devices, for example, because older predicate devices may have long-term safety and effectiveness data that establishes a history of safe and effective use or may continue to be the gold standard for patient care or device performance.

Therefore, in one of the new draft guidances, CDRH recommends utilization of certain best practices when selecting a predicate device rather than focusing solely on the predicate's age. CDRH also requested feedback on other steps that the FDA could take to promote the development of safer, more effective 510(k) devices. Additional areas identified by the public comments where clarity and transparency would be helpful included the use of clinical data in 510(k) submissions and recommendations for 510(k) implants. These topic areas are the subject matter of the other two draft guidances we are issuing today.

In a parallel effort to assure that preamendment devices remain safe and effective, the FDA is engaging with manufacturers that are marketing devices that have been listed with a preamendment status. Devices with preamendment status are those that were legally marketed in the U.S. by a manufacturer before May 28, 1976, and which have not been significantly changed or modified since May 28, 1976, and for which a regulation requiring an application for premarket approval has not been published by CDRH. We are engaging with manufacturers of devices with preamendment status to ensure that the appropriate regulatory requirements are met for those devices, given that, over the course of four decades, certain changes may have been made that, in the aggregate over time, could trigger the need for a premarket submission.

Today's New Draft Guidances to Further Modernize the 510(k) Program

The three draft guidances propose recommendations on best practices for selecting a predicate device, situations when clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) submissions for implanted devices. Specifically:

Best Practices for Selecting a Predicate Device to Encourage Evolving to Safer and More Effective Devices

CDRH believes applying a set of best practices for selecting a predicate device will encourage the evolution of safer and more effective medical devices in the 510(k) Program and has described these best practices in the draft guidance, Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The use of best practices, such as choosing a predicate device that meets or exceeds expected safety and performance or that does not have unmitigated use-related or design-related safety issues, is intended to advance safety and innovation by continually promoting the selection of safe and effective devices to be used as predicates in the 510(k) premarket review process, which ultimately improves the safety, effectiveness, and quality of devices marketed through the 510(k) Program. CDRH has provided these best practices to assist manufacturers in selecting a predicate device for their 510(k) submission and recommends that manufacturers describe how the best practices were used to select the predicate device in the 510(k) Summary for their new device. Once finalized, this guidance is expected to promote transparency to the public regarding the process of selecting a predicate device using these best practices.

Clarity about When Clinical Data May be Needed to Demonstrate Substantial Equivalence in a 510(k) Submission

In our new draft guidance, Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions, we expand on the policies initially described in the 510(k) Program Guidance to clarify and provide additional context and examples regarding when clinical data may or may not be needed to support a 510(k) submission. These recommendations, once finalized, are intended to advance safety and innovation by enhancing clarity and predictability about when clinical data in a 510(k) submission are necessary, so that submitters provide the appropriate data to support a substantial equivalence determination. For example, innovation in materials could lead to differences in the technological characteristics of the new device and the predicate device, which may result in the need for clinical data in a 510(k) submission. As another example, a newly identified risk in the predicate device that impacts the device's safety profile may prompt a need for clinical data for a device of the same type to determine substantial equivalence in light of the new scientific information.

Clarity about Performance Testing Recommendations for Implants to Promote More Consistent Reviews

In our new draft guidance, Evidentiary Expectations for 510(k) Implant Devices, we provide updated recommendations for manufacturers on the design and execution of appropriate performance testing for 510(k) implant devices, as well as the appropriate content and labeling information to include in 510(k) submissions for those devices. For example, our guidance includes new recommendations for patient labeling and "implant ID cards."

We intend to finalize these three guidances and use other opportunities to continue to strengthen and modernize other aspects of the 510(k) Program to help deliver safe, effective and high-quality medical devices to patients. This is part of our ongoing commitment to continue protecting and promoting public health.

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