HR1539-119

What This Bill Does

This bill allows medical device manufacturers to provide required labeling information electronically rather than on paper. It amends the Federal Food, Drug, and Cosmetic Act to permit device labeling to be made available through digital means, while still requiring manufacturers to provide paper copies upon request at no additional cost.

Who Benefits and How

Medical device manufacturers benefit significantly from reduced printing and packaging costs, as they can shift to electronic labeling. This is especially advantageous for devices that require frequent labeling updates or have extensive instructions. Healthcare professionals may also benefit from easier access to up-to-date labeling information through digital platforms.

Who Bears the Burden and How

The FDA faces an increased regulatory workload, as it gains authority to issue orders establishing additional requirements or exceptions for electronic labeling on a device-by-device basis. Some end users, particularly elderly patients or those without easy internet access, may face challenges accessing electronic labeling, though the bill requires manufacturers to provide paper copies upon request.

Key Provisions

• Permits medical device labeling to be provided solely through electronic means if readily accessible to intended users
• Requires manufacturers to provide paper labeling upon request at no additional cost
• Mandates that physical labels on devices still include all required compliance information
• Grants the FDA authority to issue orders with additional requirements or exceptions for specific device types
• Applies to all devices including in vitro diagnostic devices