The 510(k) Program accounts for most new medical devices the FDA reviews to reasonably assure their safety and effectiveness. Through the 510(k) Program, the FDA conducts a comprehensive review of safety and performance data to determine if a new device is substantially equivalent to a device that is already on the market (a legally marketed predicate device).
To help the FDA staff conduct a thorough review, the 510(k) premarket review process includes many safeguards, which we continue to improve, to ensure the appropriate information is included in 510(k) submissions. Some of these safeguards include steps such as the Refuse to Accept Policy, Substantive Review of a 510(k) submission, and requests for Additional Information in a 510(k) submission. These steps, in addition to our latest actions described below, are intended to strengthen the 510(k) Program.
To keep pace with the increasing complexity of rapidly evolving technology, the FDA continues to advance new policy initiatives to strengthen the 510(k) Program to meet both patient needs and changes to the device marketplace. This update outlines the FDA's latest improvements to strengthen the 510(k) Program and enable patients to access and benefit from new and innovative technologies, while meeting the FDA's standards for safety and effectiveness.
Safety and Performance
In September 2019, the FDA launched the Safety and Performance Based Pathway. This is an optional pathway for certain, well understood device types. Through this pathway, a sponsor can demonstrate its device meets FDA-identified performance criteria to show that it is as safe and effective as a legally marketed device. Since the issuance of the Safety and Performance Based Pathway final guidance, the FDA has published ten device-specific final guidances for devices with corresponding FDA-identified performance criteria, ranging from bone screws to magnetic resonance coils. The FDA continues to develop device-specific guidances for well understood device types that may be appropriate for this optional pathway.
In February 2020, the FDA launched the voluntary pilot program: electronic Submission Template And Resource (eSTAR). eSTAR is an interactive, PDF-based electronic submission template that may be used by medical device submitters to prepare certain premarket submissions for a device. At this time, eSTAR is available for voluntary use for all 510(k) submissions and De Novo requests. eSTAR aims to improve consistency and efficiency in how industry prepares premarket submissions and how the FDA reviews these submissions. In addition, eSTAR was a step toward fulfilling our Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment to streamline the 510(k) submission and review processes, which may help promote patients' timely access to safe, effective, and high-quality medical devices.
Starting October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR.
*As noted in the final guidance, Electronic Submission Template for Medical Device 510(k) Submissions, all 510(k) submissions, including original submissions for Traditional, Special, and Abbreviated 510(k)s, and subsequent Supplements and Amendments, and any other subsequent submissions to an original submission unless exempted in Section VI.A Waivers and Exemptions From Electronic Submission Requirements of the guidance, are required to be submitted as electronic submissions. eSTAR is the only currently available electronic submission template to facilitate the preparation of electronic 510(k) submissions.
The FDA Continues to Modernize the 510(k) Program
In September 2023, the FDA released three draft guidances that, when finalized, are intended to provide updated recommendations on specific aspects of the 510(k) Program. The three draft guidances are:
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
- Evidentiary Expectations for 510(k) Implant Devices
These draft guidances are informed by a 2019 request for public feedback to continue to modernize the 510(k) Program while promoting patient safety. The issuance of these draft guidance documents signifies new steps the FDA is taking to further modernize the 510(k) Program. These guidances are not currently for implementation, but when finalized, may help improve the safety and effectiveness of devices in the 510(k) Program over time.
Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
The FDA wrote a draft guidance outlining recommended best practices for selecting a predicate device. The factors include that the predicate device:
- Was cleared using well-established methods
- Meets or exceeds expected safety and performance
- Does not have unmitigated use-related or design-related safety issues, and
- Is not associated with a design-related recall.
The draft guidance explains how use of these best practices is expected to benefit manufacturers, the FDA, and public health, and provides examples of how to apply these best practices. The FDA believes use of these best practices outlined in this draft guidance, once finalized, will encourage the evolution of safer and more effective medical devices in the 510(k) Program over time.
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
Through this draft guidance, the FDA provides transparency on when the FDA recommends manufacturers submit clinical data in their 510(k) submission. Specifically, this draft guidance clarifies certain situations when clinical data may or may not be needed to support a 510(k) submission, as initially described in the 510(k) Program guidance. It also provides examples to illustrate when clinical data may or may not be needed in a 510(k) submission.
The FDA believes these recommendations, once finalized, will enhance predictability, consistency, and transparency in the use of clinical data in 510(k) submissions and lead to the appropriate data the FDA needs to make substantial equivalence determinations to assure the safety and effectiveness of devices.
Evidentiary Expectations for 510(k) Implant Devices
This draft guidance is expected to enhance predictability for sponsors in preparing 510(k) submissions for implants and promote consistency in review of implants through the 510(k) Program. The draft guidance is intended to:
- Serve as a primary resource on expectations for all 510(k) implant devices, generally, while device-specific guidances provide further specificity for a given device type
- Assist industry in design and execution of appropriate performance testing to support 510(k) submissions for implant devices
- Provide recommendations for content and labeling to include in 510(k) submissions for implant devices, and
- Convey that the FDA considers the patient experience to be paramount in improving implant device safety, and encourages the collection, analysis, and integration of patient experience data for implants to support 510(k) submissions for those devices.
This draft guidance discusses review considerations that apply to all implanted devices reviewed in the 510(k) Program. The FDA expects this guidance, once finalized, will enhance transparency, consistency, and predictability of the 510(k) premarket review process for implanted medical devices.
FDA Engages with Companies Marketing Preamendment Devices
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
- 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 the FDA.
The FDA is working to ensure that the preamendment status for such listed devices is still applicable for devices currently marketed. The FDA is 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 could trigger the need for a premarket submission.
The FDA recommends that manufacturers of preamendments devices compare the currently marketed version of the device to the preamendment version of the device to determine if the marketed device has been changed or modified in a way that could trigger the regulatory threshold to require 510(k) submission. Manufacturers are welcome to discuss with the Agency a proposed plan for submission and the FDA review of a premarket submission for their device, if appropriate.