The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you.
Provided, That if at the time the notification is sent, the Secretary has approved a plan for the repair, replacement or refund of the product, the notification may include the details of the approved plan in lieu of the above statement.
Important-Electronic Product Radiation Warning
The statement shall be in three lines, all capitals, and centered. "Important" shall be in 36-point Gothic Bold type. "Electronic Product" and "Radiation Warning" shall be in 36-point Gothic Condensed type.
21 C.F.R. §1003.21