December 6, 2023
As members of the Patient, Consumer, and Public Health Coalition, we appreciate the opportunity to comment on the FDA Proposed Guidance on Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission.
The Coalition includes nonprofit organizations representing millions of patients, consumers, researchers, and doctors united to ensure that medical treatments are safe and effective. The coalition does not have paid staff and does not accept funding from any outside sources, so we have no conflicts of interest. Since many members of our coalition organizations have been harmed by medical devices cleared through the 510(k) pathway, several of the organizations have submitted their own comments to the docket, resulting in fewer members than usual submitting this comment.
FDA recommends the submitter include within their 510(k) submission how they used the best practices identified in this guidance in selecting the predicate device(s) used to support their 510(k) submission. We agree. However, the FDA draft guidance specifies that if a valid predicate device consistent with the best practices identified in this guidance is not available, the company should describe in the 510(k) submission how any known concerns with the valid predicate device have been mitigated with the subject device (e.g., design features, performance testing), describing the ways performance testing was conducted to address any known safety or effectiveness concerns with the predicate device. We disagree. If no valid predicate device could be selected on the basis of the best practices identified in this guidance, then there is no predicate that should be considered substantially equivalent to the new device, and the new device should be submitted through the de novo pathway or a premarket approval application (PMA).
We agree with the major points the FDA Draft Guidance states regarding best practices for selecting predicates, as follows. Although these suggestions seem self-evident, it may be that companies need to be encouraged to follow these recommendations, and FDA needs to make it clear that FDA clearance depends on following these best practices.
- Predicate devices should be cleared using well established methods
- Select predicate devices that meet or exceed expected safety and performance
We strongly agree with the FDA that it is “a best practice to select a valid predicate device that continues to perform safely and as intended by the manufacturer during use in its intended environment of use whenever possible” and “recommends selecting a valid predicate device after considering how any reported medical device-related adverse events, malfunctions, or deaths may have a role in the safety and effectiveness of the device. …Also, subsequent changes made to the device, including material changes, or its manufacturing process may lead to unanticipated effects that cannot be comprehensively captured during premarket review.” We also agree with the FDA suggestion that when selecting a predicate, companies should search databases for any reports of unexpected injury, deaths, or malfunctions associated with the available valid predicate devices.”
- Predicate devices should not have unmitigated use-related or design-related safety issues
- Predicate devices should not have an associated design-related recall
We agree with the FDA recommendation to select a valid predicate device that has not been subject to a design-related recall. Research indicates that when a predicate has been subject to a Class I recall, the new substantially equivalent device is more likely to subsequently also be subject to a Class I recall.
We also agree with the FDA’s emphasis on improving the 510(k) Summary. The 510(k) Summary is a document that is required to provide an adequate summary of any information regarding safety and effectiveness and must include all the elements identified in 21 CFR 302 807.92.35 A 510(k). We agree with the FDA that the “summary must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence (21 CFR 807.92(a)). In an analysis of the summaries provided on the FDA website, however, the National Center for Health Research found that evidence regarding safety and effectiveness was available on a very small percentage of these summaries. This is problematic since the FDA agrees that the 510(k) Summary is a document drafted by the submitter and is included in the 510(k), and should accurately reflect FDA’s decision-making process.
In conclusion, the Guidance provides very important recommendations regarding best practices for selecting a predicate device, and the FDA should follow those recommendations as it reviews 510(k) submissions. If they are not followed, or if a valid predicate consistent with the best practices identified in this guidance is not available, the FDA should not clear the new device through the 510(k) pathway.
Breast Implant Safety Alliance
Medical Device Problems
Mothers Against Medical Error
National Center for Health Research
Our Bodies Ourselves
The TMJ Association
1. Kadakia, K.T., Dhruva, S.S., Caraballo, C., Ross, J.S., Krumholz, H.M. (2023). Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls. JAMA. 329(2):136–143. doi:10.1001/jama.2022.23279
2. Zuckerman, D., Brown, P., & Das, A. (2014). Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA internal medicine, 174(11), 1781–1787. https://doi.org/10.1001/jamainternmed.2014.4193