FDA Downgrades Headache Treatment Devices To Class II

By Nick Otto

The FDA has issued a final reclassification notice that eases regulatory requirements for manufacturers of neurostimulators used to treat headaches, which should speed the process of getting those devices to market.

Transcutaneous electrical nerve stimulation devices are designed to alleviate headaches by applying electrical currents to a patient’s cranium through electrodes placed on the skin. The devices had no “substantially equivalent” products on the market prior to the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. This relegatedg them to “postamendments devices,” which are automatically classified as Class III devices and require premarket approval (PMA).

In December 2012, STX-Med submitted a request for classification of the Cefaly Device, recommending it be reclassified as a Class II. Following review of information submitted by the device maker in a de novo request, the agency decided that the device could be classified as Class II with the establishment of special controls. The “FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device,” according to the Federal Register notice.

Some of the special controls listed in the Federal Register notice include:

• Appropriate software verification, validation, and hazard analysis must be performed.
• The patient-contacting components of the device must be demonstrated to be biocompatible.
• Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
• Clinical performance data must demonstrate that the product is safe and effective. 

Additionally, the FDA says the device labeling must contain appropriate contraindications, warnings, and precautions along with risk and clinical performance data summaries.

Until the broader reclassification becomes official on Aug. 4, similar devices will still need to register as Class III.

The agency also last week made effective the downgrade of a similar headache-treatment product — transcranial magnetic stimulators — from Class III to Class II with special controls.

In agreeing to the change, the FDA says similar controls will be put in place for transcutaneous electrical nerve stimulation, such as including mandatory analyses and clinical and nonclinical testing before the products are brought to market.