Medical Device Electronic Labeling Act expands electronic labeling for medical devices.
The Medical Device Electronic Labeling Act amends the Federal Food, Drug, and Cosmetic Act to allow required labeling for medical devices to be made available solely by electronic means. This applies to devices where the labeling is readily accessible to intended users and manufacturers provide the information in paper form upon request. The Secretary of Health and Human Services may establish additional requirements or exceptions for device labels.
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- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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