Bill > HR6594

This bill aims to improve medical device recall notifications by establishing a comprehensive electronic system for reporting and communicating device recalls. Specifically, the bill requires the Secretary of Health and Human Services to create a standardized electronic format for recall notifications within two years, which must include mandatory data elements such as manufacturer contact information, reasons for recall, unique device identifiers, and specific risk information for both healthcare professionals and patients. Manufacturers and importers will be required to submit recall notifications electronically to the Secretary within 180 days of the system's establishment, with an initial review process mandating that the Secretary respond within three business days about what information should be shared. The bill also establishes a publicly accessible electronic database for device notifications and introduces a patient notification requirement for certain types of recalls, particularly for implanted, life-sustaining, life-supporting, or pediatric devices. The legislation includes penalties for non-compliance and authorizes approximately $10.4 million in funding over five years to implement the new notification system. This bill is designed to enhance patient safety by creating a more efficient and transparent process for communicating potential medical device risks.

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https://www.congress.gov/bill/119th-congress/house-bill/6594/all-info