FDA to Review Berkshire’s 510(k) Submission for Remote Drug-Delivery System

The FDA has accepted Berkshire Biomedical’s 510(k) premarket submission for its Computerized Oral Prescription Administration (COPA) system, a platform designed for the remote management of therapy regimens.

The system, which monitors patients’ adherence to drug treatments, is designed to be used by medical providers to help them virtually manage therapeutic regimens for patients at home or in the clinic.

The COPA system enables the prescribed drugs to be stored in a delivery unit for remote scheduling and notifies patients when to take their medications. It can also release prescribed medications into a mouthpiece device on the patient’s command.