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PUBLIC SUBMISSION

As of: 10/14/26, 11:24 AM
Received: September 15, 2026
Status: Posted
Posted: September 23, 2026
Tracking No. mu2-be3g-7fit
Comments Due: September 15, 2026
Submission Type: Web

Docket: FDA-2026-N-7129
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event
Program for Medical Devices: (Medical Product Safety Network (MedSun))
Comment On: FDA-2026-N-7129-0001
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event
Program for Medical Devices: (Medical Product Safety Network (MedSun))
Document: FDA-2026-N-7129-0003
Comment from inventhealth.care

Submitter Information
Organization: inventhealth.care

General Comment
MedSun is an indispensable sentinel network whose targeted, high-precision clinical reporting enables
early safety signal detection and proactive device hazard mitigation before patient harm can occur.
inventhealth.care requests that the Office of Management and Budget authorize the proposed information
collection renewal as submitted.
1. Practical Utility of a Low-Friction Voluntary Program
MedSun’s primary value lies in its streamlined, voluntary framework. Because participation is voluntary
across the approximately 300 member facilities, keeping the reporting portal simple ensures high ongoing
engagement from clinical staff without imposing heavy administrative overhead. MedSun's practical
utility stems directly from its nature as a lightweight, low-friction surveillance tool.
2. Accuracy of the Burden Estimate and High Value of the Supplemental Questions
The FDA's estimated average of 0.5 burden hours (30 minutes) and operational costs accurately reflects
the standard effort required from respondents. The vast majority of routine MedSun intakes consist of
concise, 1-to-2 sentence summaries identifying the device problem. While specialized, complex events
occur, they typically require no more than a paragraph or two. Furthermore, the FDA’s informal
"supplemental follow-up questions" are infrequent, brief administrative clarifications that are already
captured within the overall 30-minute average. Creating a separate line item for these occasional followup inquiries would add unnecessary paperwork clutter to the OMB filing without offering better
accounting accuracy. Evaluating the collection based on this high-volume baseline of straightforward
events justifies the estimated burden calculation.
3. Maintaining Regulatory Boundaries and Operational Simplicity
Mandating complex third-party system integrations, such as direct EHR data pulls, would diminish the
practical utility of the collection. Section 519 of the FD&C Act, implemented under Part 803, legally
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requires user facilities to report incidents directly to the FDA under strict deadlines. This statutory
requirement serves as the formal regulatory compliance mechanism with enforcement discretion.
MedSun, on the other hand, is not a regulatory compliance mechanism; rather, it functions as an optional,
high-detail sentinel network. MedSun works precisely because it remains a lightweight, direct reporting
tool.
inventhealth.care respectfully urges the Office of Management and Budget (OMB) to approve the
collection extension as currently proposed.
Respectfully submitted,
inventhealth.care

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