On February 3, 2015, Atrium and three other affiliated Maquet companies reached an agreement concerning a Consent Decree (Decree) with the U.S. Food and Drug Administration (FDA). This voluntary agreement has been approved by a federal judge in New Hampshire and it establishes a framework that provides assurances to FDA that we will complete the improvements currently underway to strengthen our quality management system.
Below is a summary of the steps that you, as the customer, need to take to obtain the products deemed medically necessary by FDA.
To continue to receive medically necessary products:
The Certificate of Medical Necessity (CMN) form must be completed and signed by an authorized representative of the customer certifying that, s/he is aware of FDA’s findings and deems the product necessary.
- Customers must provide the completed CMN form to Atrium as soon as possible in order to continue receiving restricted products.
- Please return the completed CMN form to Atrium in one of three ways: