FDA Seeks to Protect Patients
Manufacturers will be notified by the Food and Drug Administration (FDA) whenever the agency determines that post-market surveillance is necessary for a given device. This may occur during the review of a firm’s marketing application, as the device goes to market or after the device has been marketed for a period of time. Companies will be required to submit a post-market surveillance plan within 30 days of receiving an order.
This mandate will affect about 30 medical devices a year, including those for which failure would likely cause severe adverse health consequences, devices implanted into the body for more than 1 year, and devices that sustain or support life and are used outside a medical facility.