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Compliance with FDA medical device regulatory requirements
The FDA medical device regulatory requirements help to ensure the distribution of only safe and effective medical devices. Here are the FDA regulatory standards for manufacturers of medical devices, including UV-C medical products.
Manufacturer and distributor registration
The FDA states that every manufacturer or distributor, including foreign ones, must electronically register and verify their establishment annually. FDA also mandates that foreign manufacturers must use a USA agent.
Medical Device Listing
The FDA expects manufacturers to list their medical devices and the activities performed on the devices during the registration process. The registration and listing of medical devices enable the FDA to be aware of devices manufactured by an establishment and their location.
Premarket Notification 510(k)
A premarket notification 510(k) is necessary before the commercial distribution or marketing of first-time medical products. Also, the FDA requires a 510(k) for changes or modifications to an existing device that could significantly affect its safety or effectiveness.
Premarket Approval
High-risk medical devices, such as class III medical devices which pose a significant risk of injury, require premarket approval. Premarket approval involves the clinical and regulatory review of class III medical devices to determine their safety and effectiveness. The premarket approval process entails supporting medical device claims using clinical data.
Investigational Device Exemption
Investigational device exemption is the process in which the FDA approves an investigational device for a clinical study to collect relevant data necessary for a premarket approval application.
Quality System Regulation
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 in producing, storing, installing, and servicing medical devices.
Labeling
The FDA expects manufacturers to correctly label medical devices and attach educational literature about their products.
Medical Device Reporting
Medical Device Reporting involves reporting incidents in which the use of a medical device led to an adverse event, injury, or death. The main purpose of medical device reporting is to identify and resolve problems related to using a medical device.
Electromagnetic compatibility and interference
A medical device may emit above-normal electromagnetic energy, which interferes with other electromagnetic medical devices in the hospital environment.
Hence, the FDA’s Center for Devices and Radiological Health (CDRH) is the regulatory body that examines and ensures that medical devices meet the standards that foster electromagnetic compatibility in health facilities.
In Summary
The FDA medical device regulatory requirements help to prevent the marketing of suboptimal medical products that are ineffective and unsafe to health care workers. Awareness of these FDA medical device standards will help you to evaluate the UV-C medical devices you use in your health facility.
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