We have received text from H.R. 6594: Medical Device Recall Improvement Act of 2025. This bill was received on 2025-12-10, and currently has 1 cosponsor.
Here is a short summary of the bill:
This bill, known as the **Medical Device Recall Improvement Act of 2025**, aims to enhance the notification process for medical device recalls by implementing an electronic system. Here’s a breakdown of what the legislation proposes:
Establishment of Electronic Notification System
Within two years of the bill's enactment, the Secretary of Health and Human Services will be required to create a standardized electronic format for medical device recall notifications. This system will facilitate quicker and more effective communication regarding device recalls.
Mandatory Content for Notifications
The electronic notification format must include specific mandatory information, which includes:
- Name of the manufacturer or importer
- Contact information and address of the manufacturer or importer
- Reason for the recall
- Details on the specific devices affected
- Unique device identifier information
- Information for healthcare professionals and user facilities regarding the recall
- Patient information, including risks presented by the device and recommended actions
Notification Process
After the Secretary establishes the electronic notification format:
- Manufacturers and importers must submit recall notifications using this electronic format, starting 180 days after the system is implemented.
- The Secretary will conduct an initial review of notifications within two business days and inform the manufacturer of necessary information to be shared with healthcare facilities.
- Following this, the manufacturers or importers must notify healthcare facilities and professionals through the established electronic format.
Public Access to Information
The Secretary will maintain an electronic, publicly accessible database containing recall notification information. This database will allow users to download data pertaining to device recalls.
Patient Notification Requirements
Recall strategies must ensure that patients treated with recalled devices are notified. Manufacturers and importers are required to send notifications that detail the risks of the device to healthcare providers, who must then communicate this information to affected patients.
Scope of Affected Devices
This notification requirement applies to specific class I, II, and III devices that are:
- Implanted in the human body
- Life-sustaining
- Life-supporting
- Used significantly in pediatric populations
Funding and Resources
The bill authorizes appropriations of funds for implementation and management over several years, including:
- $6.7 million for fiscal year 2026
- $1.7 million for fiscal year 2027
- $1 million for fiscal years 2028 through 2030
Prohibited Acts
The bill adds penalties for manufacturers or importers that fail to comply with the notification requirements outlined in the new sections related to risk communication and recall notifications.
Relevant Companies
- MDT (Medtronic plc) - A major player in medical devices that could face increased scrutiny and operational changes based on enhanced recall notification requirements.
- BDX (Becton, Dickinson and Company) - With a wide range of medical devices, they will likely need to adapt to the new electronic notification system.
- ABT (Abbott Laboratories) - As a manufacturer of various medical devices, compliance with the new regulations will be crucial for risk management and patient communication.
Representative Janice D. Schakowsky Bill Proposals
Here are some bills which have recently been proposed by Representative Janice D. Schakowsky:
- H.R.6818: To extend protections to part-time workers in the areas of family and medical leave and to ensure equitable treatment in the workplace.
- H.R.6594: To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes.
- H.R.6116: Safe Hydration is an American Right in Energy Development Act of 2025
- H.R.5605: Medical Device Nonvisual Accessibility Act of 2025
- H.R.5489: Future Generations Protection Act
- H.R.4725: TRUTH in Labeling Act
You can track bills proposed by Representative Janice D. Schakowsky on Quiver Quantitative's politician page for Schakowsky.
Representative Janice D. Schakowsky Net Worth
Quiver Quantitative estimates that Representative Janice D. Schakowsky is worth $586.0K, as of December 29th, 2025. This is the 387th highest net worth in Congress, per our live estimates.
Schakowsky has approximately $0 invested in publicly traded assets which Quiver is able to track live.
You can track Representative Janice D. Schakowsky's net worth on Quiver Quantitative's politician page for Schakowsky.
This article is not financial advice. See Quiver Quantitative's disclaimers for more information.
