FDA Seeks OMB Clearance to Continue MedSun Medical Device Adverse Event Surveillance

The U.S. Food and Drug Administration (FDA) has submitted a proposed extension of its Medical Product Safety Network (MedSun) information collection program to the Office of Management and Budget (OMB) for review and clearance.

The notice was published in the Federal Register on 8 October 2026, under Docket No. FDA-2026-N-7129. Written comments may be submitted until 9 November 2026. 1791523047536

What Is MedSun?

MedSun is FDA’s national surveillance network designed to collect high-quality information on medical device problems identified in clinical use.

The program was developed under Section 519 of the Federal Food, Drug, and Cosmetic Act, which gives FDA authority to require reporting of medical device-related:

• deaths;

• serious injuries;

• malfunctions.

User facilities are also subject to reporting obligations for certain device-related deaths and serious injuries. 1791523047536

A Network of Clinical Facilities

The MedSun model is based on a representative group of healthcare facilities rather than universal user-facility reporting.

FDA explains that the program allows the Agency to operate a national surveillance network composed of well-trained clinical facilities capable of providing high-quality data on medical devices in real-world clinical use. 1791523047536

Participation in MedSun is voluntary and currently involves approximately 300 facilities. 1791523047536

Electronic Adverse Event Data Collection

FDA is seeking OMB clearance to continue using electronic data collection from MedSun participants.

The information collected includes:

• medical device and tissue product adverse events;

• facility demographic information;

• additional follow-up questions;

• contextual information to help FDA better understand the causes of reported events. 1791523047536

Reporting Burden

FDA estimates that participating facilities submit an average of 18 reports per site annually.

Across approximately 300 facilities, this results in an estimated 5,400 annual responses.

FDA currently estimates an average reporting burden of 30 minutes per response, corresponding to approximately 2,700 total hours per year. 1791523047536

Focus on Specialized Clinical Environments

FDA notes that MedSun actively promotes reporting from specialized hospital areas, including:

• pediatric intensive care units;

• electrophysiology laboratories;

• hospital laboratories. 1791523047536

These environments may provide particularly valuable insight into complex device-related problems.

Public Comment on Reporting Burden

FDA previously published a 60-day notice in July 2026 and received one public comment from a quality engineer with experience in medical device manufacturing, adverse event investigation and CAPA program management. 1791523047536

The commenter questioned whether the current 30-minute estimate adequately reflects the time required for more complex reports involving:

• serious injuries;

• deaths;

• multiple interacting devices;

• specialized clinical environments. 1791523047536

FDA responded that the 0.5-hour estimate remains a reasonable average for Paperwork Reduction Act purposes but stated that it would consider a more stratified burden estimation approach in the next renewal cycle. 1791523047536

Suggested Improvements to MedSun

The public comment also proposed several potential improvements to MedSun data quality and reporting efficiency, including:

• use of IMDRF adverse event codes;

• UDI prompts with auto-population;

• tiered short and long reporting forms;

• EHR integration using FHIR-based data exchange;

• aggregate feedback to participating facilities. 1791523047536

FDA stated that these suggestions fall outside the scope of the current PRA clearance, but may be considered as part of ongoing MedSun development and future updates to the collection instrument. 1791523047536

Why MedSun Matters

MedSun supports FDA’s ability to detect and better understand medical device safety issues that may emerge during real-world clinical use.

The program complements mandatory Medical Device Reporting by providing more detailed and context-rich information from participating healthcare facilities.

This can help support:

• signal detection;

• adverse event investigation;

• post-market surveillance;

• device risk assessment;

• regulatory decision-making.

Impact on Manufacturers and Healthcare Facilities

For medical device manufacturers, MedSun remains an important part of the U.S. post-market surveillance environment.

Reports originating from participating facilities may contribute to the identification of:

• unexpected device failures;

• recurring malfunctions;

• serious injury trends;

• use-related issues;

• safety signals requiring additional investigation.

Healthcare facilities participating in the network should continue to maintain robust processes for identifying, documenting and electronically reporting device-related events.

Next Steps

The current notice seeks OMB review and clearance for an extension of OMB Control Number 0910-0471.

Comments on the information collection may be submitted until 9 November 2026. 1791523047536