Sponsors (2)
Introduced December 10, 2025 by Janice D. Schakowsky · Last progress December 10, 2025
The bill improves patient safety and transparency by standardizing and speeding medical device recall notifications and strengthening enforcement, at the cost of compliance and IT burdens for manufacturers and health systems, potential privacy risks from publicized data, and new enforcement exposure for organizations.
Patients — including people with implanted or life‑sustaining devices, those with chronic conditions, and children — will get clearer, standardized, faster recall and safety information that is accessible to the public, improving the ability of patients and providers to identify risks and take protective actions.
Device manufacturers, importers, and health care organizations will have a single standardized electronic channel and uniform data fields for recalls and notifications, reducing confusion and speeding two‑way communications and responses across the supply chain and care settings.
Making required notifications enforceable as violations of the FD&C Act and strengthening enforcement incentives will increase the likelihood that manufacturers and distributors provide timely safety notices, improving regulatory oversight and completeness of reporting.
Manufacturers and importers — particularly small businesses — must adopt the new electronic system within 180 days, creating IT, implementation, and compliance costs that may be burdensome for smaller firms.
Hospitals, clinicians, and health systems will face added obligations to receive, review, and share patient risk information and to comply with new notification processes, increasing administrative workload and operational costs.
Companies and facilities that fail to meet or that dispute notification requirements could face FDA enforcement actions, increasing legal exposure and compliance costs for affected firms and health providers.
Based on analysis of 3 sections of legislative text.
Requires medical device manufacturers and importers to submit standardized electronic recall notifications and directs HHS to publish a public, downloadable electronic database of device recall notices. It also requires patient notification for certain high-risk out-of-facility devices and makes failure to submit required notifications a violation of the Federal Food, Drug, and Cosmetic Act. Sets firm agency timelines for creating the electronic form (within 2 years) and for initial agency review (2 business days) and requires manufacturers to begin using the system 180 days after the form is published; authorizes modest, multi-year funding to support implementation.