Compliancewith FDA medical device regulations.
FDA medical device regulations help ensure the distribution of only safe and effective medical devices. Here are the FDA regulatory standards for medical device manufacturers, including UV-C medical products.
Registration of manufacturers and distributors
The FDA states that every manufacturer or distributor, including those coming from abroad, must electronically register and verify its establishment annually. The FDA also requires foreign manufacturers to use a U.S. agent.
Medical device list
The FDA expects manufacturers to list their medical devices and activities performed during the registration process. By registering and listing medical devices, the FDA is aware of a company's manufactured devices and their location.
Premarket Notification 510(k)
A premarket notification 510(k) is required for commercial distribution or marketing of first-time medical products. The FDA also requires a 510(k) for changes or modifications to an existing device that may significantly affect its safety or effectiveness.
A pre-market approval
High-risk medical devices, such as Class III medical devices that pose a significant risk of injury, require premarket approval. Premarket approval refers to the clinical and regulatory evaluation of Class III medical devices to determine their safety and effectiveness. The premarket approval process involves substantiating medical device claims with clinical data.
Research equipement exemption
Extemption for investigational drugsis the process by which the FDA approves an investigational drug for a clinical trial to collect relevant data needed to apply for marketing approval.
Regulation quality system
The FDA uses its quality system requirements to assess the quality of finished medical products. During quality system regulation, the FDA inspects the methods manufacturers use to produce, store, install and maintain medical devices.
Medical device reporting refers to the reporting of incidents in which the use of a medical device has resulted in an adverse event, injury or death. The main purpose of medical device reporting is to identify and resolve problems associated with the use of a medical device.
Electromagnetic compatibility and interference
A medical device may emit above-normal electromagnetic energy that interferes with other electromagnetic medical devices in the hospital environment.
That is why the FDA's Center for Devices and Radiological Health (CDRH) is the regulatory body that examines and ensures that medical devices meet standards that promote electromagnetic compatibility in health care facilities.
FDA medical device regulations help prevent medical products from being marketed that are suboptimal and unsafe for healthcare workers. Knowledge of these FDA medical device standards helps evaluate the UV-C medical devices used in your own healthcare facility.