What regulatory framework must medical device manufacturers comply with according to establishment listings?

The regulatory framework that medical device manufacturers must comply with concerning establishment listings is found in 21 CFR 807. This regulation outlines the requirements for device registration and listing with the FDA. Under 21 CFR 807, manufacturers are obligated to provide the FDA with their establishment information, including the name and address of the establishment, the type of device being manufactured, and a listing of all devices they produce. This is crucial for ensuring that the FDA maintains an accurate database of devices on the market, which is essential for monitoring device safety and effectiveness.

In contrast, 21 CFR 801 pertains to labeling requirements for medical devices, ensuring that they are labeled accurately and provide necessary information to users and healthcare professionals. 21 CFR 803 deals with the reporting of adverse events and device defects, which is important but not directly associated with the establishment listing requirements. Lastly, 21 CFR 820 establishes the Quality System Regulation, which details the quality management practices that manufacturers must follow to ensure their products are safe and effective. While each of these regulations is vital to the overall compliance framework for medical device manufacturers, it is 21 CFR 807 that specifically governs the registration and listing process.