FDA can take several actions to protect public health. Enforcement actions may follow from violations uncovered by FDA during Quality System inspections, reports from competitors, and FDA monitoring of industry practices. FDA usually works with the manufacturer to achieve voluntary correction of violations.
Postmarket
When initiated, a recall serves to protect the public health from products that present a risk of injury, gross deception or are otherwise defective. Depending on the nature of the violation and the risk to public health, a recall can include actions ranging from a simple labeling change, an in-field correction or a full or partial removal of the product from the market. Medical device recalls are typically conducted voluntarily, under 21 CFR 7, by the manufacturer or distributor.
FDA has the authority to order manufacturers of certain medical devices to establish and maintain systems to track their devices (21 CFR 821). This is to ensure manufacturers can expeditiously remove a device from the market if necessary and notify patients and providers of any significant issues with a device.
FDA has the authority to order manufacturers of certain medical devices to establish and maintain systems to track their devices (21 CFR 821). This is to ensure manufacturers can expeditiously remove a device from the market if necessary and notify patients and providers of any significant issues with a device.
The Quality System (QS) regulation (21 CFR Part 820) is designed to ensure that manufacturers have procedures and processes in place to produce safe and effective devices. QS requirements cover topics including: quality management and organization, device design, equipment, purchasing and handling of components, production and process controls, packaging and labeling controls, distribution, installation, complaint handling, servicing, and recordkeeping.
FDA has a range of requirements that can be imposed on manufacturers regarding postmarket surveillance activities.
FDA inspects medical device manufacturers to evaluate their compliance with the Quality System (QS) regulation and other pertinent requirements. Inspections assess the firm’s systems, processes and procedures to ensure that manufacturers can produce devices in a consistent manner that meets all specifications.
Post-marketing surveillance of adverse events involving medical devices is the responsibility of both the device manufacturer and the health care facility utilizing the device. Medical Device Reporting (MDR) regulations require manufacturers to report to FDA device-related incidents, deaths, serious injuries, and device malfunctions which are likely to cause or contribute to death or serious injury if they were to occur. Health care facilities are required to report patient deaths suspected of being associated with devices to both the manufacturer and FDA.