Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for Evidentiary Expectations for 510(k) Implant Devices

December 6, 2023: In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to institute stronger standards to determine clinically meaningful substantial equivalence for 510(k) clearance.

The post Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for Evidentiary Expectations for 510(k) Implant Devices appeared first on National Center for Health Research.

December 6, 2023

FDA-2023-D-3132

As members of the Patient, Consumer, and Public Health Coalition, we appreciate the opportunity to comment on the Food and Drug Administration (FDA) Draft Guidance on the Evidentiary Expectations for 510(k) Implant Devices.

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.

We are pleased to see the FDA take steps towards improving the highly flawed 510(k) approval process. Since implanted medical devices are part of FDA’s definition of high-risk devices, we are deeply concerned that most implanted medical devices are cleared under the 510(k) pathway and have undergone little or no publicly available clinical trials in humans.[1]^,[2] Most patients using these products assume that all medical devices cleared by FDA have been stringently tested in clinical trials, as is required for FDA-approved drugs. This belief is particularly strong for implanted devices, which patients and their physicians consider to be high-risk.

Section D of the guidance regarding clinical performance testing states: “While clinical data is not generally necessary to demonstrate substantial equivalence in most 510(k) submissions, there are scenarios where clinical data may be needed to support an SE determination.” Unfortunately, clinical trials are rarely required for the 510(k) process, and usually no clinical data of any kind are provided to show safety or effectiveness, even for implanted devices.1,2 We urge that a greater emphasis be placed on essential safety and efficacy information that can only be provided by clinical data, as opposed to the current reliance on non-clinical and occasionally post-market data.

Given the significant risks for patient harm that implanted devices pose, it is inadequate for predicates to be used as evidence for approval simply because they mirror the intended use of a device under review. We strongly urge a more stringent definition of substantial equivalence that requires evidence of the similarities in materials, mechanism of action, and evidence of safety and effectiveness; if these standards are not met, clinical trials should be required.

We support FDA’s recommendations regarding the collection, analysis, and integration of patient experience data for implants. However, in this guidance FDA clearly recognizes that patient information has been used as valid scientific evidence to support clearance of expanded indications for use, but fails to recognize that patients’ adverse event reports should have at least equal weight when evaluating safety risks and efficacy. We strongly urge the FDA to give priority attention to the red flags indicating patient harm that are present in these reports.

Regarding the standards provided in the guidance on labeling, manufacturers should directly provide information for the practitioner and also for patients about the known and potential risks of an implanted device. This is essential so that patients and their providers can make informed decisions before using an implanted device, as well as after a device is implanted. We also support the guidance recommendation that certain information be provided on Implant ID cards, including but not limited to:

• Implant identifying information (such as the UDI and barcode), including model name and manufacturer, and implant location;
• Details regarding device composition and patient contacting materials, including known information related to any allergic reactions;
• And information regarding how to report malfunctions or other adverse events to the manufacturer.

We also recommend that the ID card include information for patients regarding how to report malfunctions or other adverse events to the manufacturer (i.e., instructions to access FDA’s MAUDE system).

Finally, we support the use of the endpoints listed in this guidance to be considered as part of a biocompatibility evaluation (lines 265-279). When traditional long-term biocompatibility studies are not appropriate, we strongly support using non-clinical evidence to assess the body’s response to wear debris and other degradation of the product over time. It is important to note that some patients respond differently to specific implants than others, and yet patients’ reported adverse events are too often ignored by implant companies and the FDA just because they are relatively rare.

In conclusion, we respectfully urge the FDA to revise the guidance to have a greater emphasis on strategies intended to protect patients from the risks of inadequately tested implanted devices. We urge that the FDA: 1) institute stronger standards to determine clinically meaningful substantial equivalence that can ensure that implanted devices are safe and effective; 2) require clinical trial data whenever possible; 3) prioritize information from patient adverse reports when evaluating these products, revising labeling, and developing patient checklists to warn patients of the risks; and 4) directly provide patients with user-friendly information in the form of short checklists and patient booklets about what is known and not known about potential risks and contraindications of the implanted device, and not just the intended benefits.

Sincerely,

Breast Implant Safety Alliance

Medical Device Problems

Mothers Against Medical Error

National Center for Health Research

Our Bodies Ourselves

The TMJ Association

Woody Matters

1. 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

2. Fox-Rawlings, S., Gottschalk, L., Doamekpor, L, & Zuckerman, D. (2018). Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? The Milbank Quarterly, Vol. 96, No. 3, 2018 (pp. 499-529).

The post Patient, Consumer, and Public Health Coalition Comments Regarding the FDA Draft Guidance Recommendations for Evidentiary Expectations for 510(k) Implant Devices appeared first on National Center for Health Research.