H.R. 2372: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2025

This bill, known as the Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act, specifically regarding medical devices. Below is a summary of its main provisions:

1. Reporting Requirements for Design and Reprocessing Changes

The bill introduces new reporting obligations for manufacturers of medical devices. Specifically:

• Manufacturers must notify the Secretary of any changes they intend to make to the design or reprocessing instructions of a device before implementing those changes.
• Failure to comply with the reporting requirements can render the device adulterated.

2. Reporting Certain Communications to Foreign Health Care Providers

The legislation requires manufacturers to provide written notice to the Secretary when they communicate significant changes to their devices or safety concerns to foreign health care providers. This notice must be given within five calendar days of such communications.

• Founded communications include device design modifications, changes to reprocessing protocols, and safety issues.

3. Rapid Assessment Tests for Reusable Devices

The bill seeks to include a category called “rapid assessment tests” that are intended to ensure that reusable medical devices are properly sanitized. The key points are:

• The definition of reusable devices is established, specifying they must be designed for multiple uses and require sanitization.
• Regulations will be created to publish a list of rapid assessment tests, with specific requirements for validation and instructions to ensure their effectiveness.

4. Development of Instructions for Use and Validation Data

Manufacturers will have to provide detailed instructions and validation data for devices subjected to the new rapid assessment tests. Important aspects include:

• The Secretary must publish a list of rapid tests within one year after the enactment, which will require validated instructions for use.
• Periodic updates to this list will be mandated to maintain current standards.
• From the date of the initial list publication, manufacturers cannot submit notifications for the clearance of a rapid assessment test unless they include the required validation data and instructions.

Relevant Companies

• None found