V. R. Pertelle
The rapidly changing nature of medical devices submitted for FDA approval for homecare will require more advanced testing technologies during the product development cycle and validation in order to assure quality, safety and effectiveness for our patients. It will also require the creation of data that can be used to quantify the unique value of the products that results in a HCPCS code with appropriate reimbursement and most importantly reduce the incidence of product recalls.
By FDA definition, a medical device is any product or equipment used to diagnose a disease or other conditions, or to cure, to treat or to prevent disease. The FDA’s Center for Devices and Radiological Health (CDRH) regulates medical devices to provide reasonable assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used in the home environment by persons who are ill or have disabilities. Examples of some home healthcare devices are ventilators and nebulizers, wheelchairs, infusion pumps, blood glucose meters, apnea monitors, and other home monitoring devices. Read More