For Cervella orders shipped within the United States, FDA requires that you obtain a Medical Device Authorization (MDA) from a licensed healthcare provider before we can ship the device to you.
We offer you two options for obtaining the Medical Device Authorization for your Cervella device:
OPTION 1: Contact your licensed healthcare provider (e.g. your doctor, therapist, NP, PA, Psychologist) and obtain the Medical Device Authorization (MDA). For your convenience, HERE is an MDA form, but your provider is free to use his/her form. You can then attach the completed form during checkout or have the provider e-mail or fax it to us directly. Indiana-based patients may also contact Indiana Health Group for consultation.
OPTION 2: If you do not have a healthcare provider, you may complete a short suitability questionnaire during check-out which will be shared, via a HIPAA-compliant process, with an independent licensed healthcare provider for review and approval. Once the order and review are complete, we will ship you the device along with a copy of the approved MDA. There is no extra cost to you for this service. If you are not found to be a suitable candidate for Cervella, you will be issued a full refund immediately. We reserve the right for the independent healthcare provider to contact you via e-mail or phone for any additional information.