Electronic Labels for Medical Devices: Easier Access to Information
New rules allow medical device manufacturers to provide instructions and warnings primarily in electronic form. Citizens can still request a paper version for free, aiming to improve access to important safety and usage information for medical products.
Key points
Medical device information (e.g., instructions, warnings) will be primarily available online, potentially making it quicker to find.
Every citizen has the right to request a free paper version of the label from the manufacturer if they prefer a traditional format.
Key information will still be on the device or its immediate packaging, and the Secretary can add further safety requirements.
Introduced
Citizen Poll