In order to use a medical device in the US, a device manufacturer has to get an approval from FDA. Invasive devices, such as neural implants, are classified as Class III and can be approved in one of two ways: 1) a comprehensive “de novo” Premarket Approval (PMA) or 2) a streamlined 510(k) clearance, also called a Premarket Notification (PMN), when the device is “substantially equivalent” to an existing approved device. The complete device development and approval process takes 4-10 years and costs $5-300 million depending on the complexity of the device and FDA approval process. Approximately 40 PMAs and 3,000 510(k) clearances are approved each year by the FDA.
Cortical and spinal neural implants are among the most invasive and, therefore, always require a PMA approval. In comparison, the “Cranial Electrotherapy Stimulator” (CES) devices, are implanted under the scalp and pose fewer surgical risks. Until recently, they required only a 510(k) clearance, and such relaxed approval process resulted in their multiple applications for neurological and psychiatric disorders, such as anxiety, depression, insomnia, chronic pain, and migraine.
In August 2011, FDA proposed a new rule to require PMAs for CES devices, and the device makers responded by proposing instead that the devices be given less stringent Class II status, which often does not require PMA approval. In February 2012, the Neurological Devices Panel of the Medical Devices Advisory Committee at the FDA advised against such downgrade, so the CES devices would still require a lengthy and expensive PMA process. According to recent estimates, an average PMA approval process would take ~27 weeks and would cost the CES device makers an additional $1 million, as compared to 510(k).