Medical Device Recall Improvement Act of 2025

Bill Number

H.R. 6594

Origin Chamber

House

Congress

119th Congress, Session 1

Status

Introduced

Latest Action

2025-12-10: Referred to the House Committee on Energy and Commerce.

Last Updated

2025-12-29T14:18:24Z

AI-Generated Summary

Purpose of the Legislation

The Medical Device Recall Improvement Act of 2025 aims to enhance the process for notifying people about medical device recalls (when a device is removed from the market or corrected due to safety issues) by requiring electronic submissions. This amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to make notifications faster, more standardized, and accessible, ultimately improving public health safety.

Key Provisions

• Electronic Notification Format (Section 518B(a)): Within 2 years of enactment, the Secretary of Health and Human Services (through the Food and Drug Administration, or FDA) must create and publish an electronic template for recall notifications. This template must include:
• Mandatory details like the manufacturer's name and contact information, the reason for the recall, the specific device involved (including its unique device identifier, a code that tracks the device), and guidance for healthcare facilities, professionals, and patients on risks and actions to reduce them.
• Optional additional elements as needed.
• Submission Requirements (Section 518B(b)):
• Manufacturers or importers must submit recall notifications to the FDA electronically, starting 180 days after the template is established.
• The FDA must review submissions within 2 business days and respond within 3 business days, specifying what information should be shared with healthcare facilities and professionals.
• Manufacturers must then notify facilities and professionals electronically after the FDA's review, with follow-up notifications as needed.
• Public Database (Section 518B(c)): The FDA must maintain a publicly accessible, downloadable online database of recall information.
• Patient Notification (Section 518C):
• For certain recalls (Class I or II for Class II or III devices—devices classified by risk level, where Class III are highest risk like implants), strategies must include notifying patients treated with the device.
• Manufacturers' notifications to facilities and professionals must include patient risk information and instructions to share it with affected patients.
• Applies to devices that are implanted, life-sustaining/supporting, or commonly used in children, if used outside facilities like hospitals.
• Facilities and professionals are not required to share patient details with manufacturers.
• Enforcement (Section 3): Adds to the FD&C Act's list of prohibited acts (violations that can lead to penalties) the failure to submit electronic notifications or provide patient notices.
• Funding (Section 518B(e)): Authorizes $6.7 million in fiscal year 2026, $1.7 million in 2027, and $1 million annually from 2028 to 2030 for implementation, including hiring staff.

Significant Changes to Existing Law

• Introduces a mandatory electronic system for all recall notifications, replacing or supplementing paper-based processes under existing FD&C Act sections (e.g., 518A and 519(g)), which previously lacked a standardized electronic format.
• Requires FDA review and guidance before public notifications, adding a layer of oversight not previously specified.
• Mandates direct patient notifications for high-risk devices in specific scenarios, expanding beyond current requirements that focus mainly on facilities and professionals.
• Creates a public database for recall data, increasing transparency compared to prior limited-access systems.
• Strengthens enforcement by explicitly listing non-compliance as a prohibited act, potentially increasing penalties (fines or seizures) for violations.

Potential Impacts

• Government Agencies: The FDA will need to develop and maintain the electronic system and database, conduct timely reviews, and hire staff, supported by authorized funding. This could streamline operations but increase workload initially.
• Citizens (Patients and Public): Faster, clearer notifications may help patients identify and mitigate risks from faulty devices (e.g., implants), potentially reducing harm. The public database improves access to recall information, empowering informed decisions.
• Healthcare Providers and Facilities: Required to receive electronic alerts and notify patients, which could improve response times but add administrative burdens without new funding specified for them.
• International Relations: Minimal direct impact, though U.S. manufacturers exporting devices may face aligned global standards, indirectly affecting trade compliance.

Main Stakeholders Affected

• Manufacturers and Importers of Medical Devices: Must adopt electronic submissions and patient notification strategies, facing compliance costs and penalties for failures.
• FDA and Federal Regulators: Responsible for creating the system, reviewing notifications, and maintaining the database.
• Device User Facilities (e.g., hospitals, nursing homes): Required to receive and act on notifications, including sharing info with patients.
• Health Professionals (e.g., doctors, nurses): Must disseminate risk information to patients.
• Patients: Benefit from targeted notifications about risks and remedies for affected devices, especially high-risk ones like implants or pediatric devices.

Notable Legal, Constitutional, or Political Implications

• Legal: Enhances FDA enforcement under the FD&C Act by adding specific prohibited acts, which could lead to more consistent litigation or administrative actions against non-compliant companies. No requirements for sharing patient data protect privacy under laws like HIPAA (Health Insurance Portability and Accountability Act).
• Constitutional: Aligns with Congress's authority to regulate interstate commerce and public health (e.g., via the Commerce Clause); no apparent free speech or due process issues, as it focuses on safety disclosures.
• Political: Supports bipartisan goals of improving medical device safety post-recall incidents (e.g., faulty implants), potentially reducing public distrust in the FDA. The bill's funding authorization signals commitment to implementation without broad budget shifts, though it may spark debates on regulatory burdens for industry.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Schakowsky, Janice D. [D-IL-9]

Cosponsors (1)

Rep. Carson, André [D-IN-7]

Recent Actions

• 2025-12-10: Referred to the House Committee on Energy and Commerce.
• 2025-12-10: Introduced in House
• 2025-12-10: Introduced in House

Bill Versions

• Medical Device Recall Improvement Act of 2025 — issued 2025-12-10 — PDF (7 pages)