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To enter the U.S. market, medical devices must meet specific requirements for FDA registration, which include:

1. Establishment Registration: Manufacturers, importers, and distributors of medical devices must register their establishments with the FDA. This registration must be renewed annually. The registration includes providing information about the business and its operations.

2. Device Classification: Determine the classification of the device (Class I, II, or III) based on its risk level and intended use. This classification affects the type of regulatory submission required. For example, Class I devices often require less stringent documentation than Class II or III devices.

3. Premarket Submission:

   • 510(k) Notification: For most Class I and II devices, manufacturers must submit a premarket notification (510(k)) to demonstrate that the device is substantially equivalent to a legally marketed device.
   • Premarket Approval (PMA): Class III devices, which are higher risk, generally require a PMA application, involving extensive clinical data and evidence of safety and effectiveness.
   • De Novo Classification: For novel devices that do not fit into existing classifications, a De Novo request may be needed to establish a new classification.

4. Labeling Requirements: The device must meet FDA labeling requirements, which include specific information about the device's intended use, instructions for use, and any warnings or precautions.

5. Quality System Regulations (QSR): Manufacturers must adhere to QSR, which involves maintaining a quality management system to ensure the device is consistently produced and controlled according to FDA standards.

6. Clinical Trials: If applicable, clinical trials must be conducted under an Investigational Device Exemption (IDE) to gather data on the device's safety and effectiveness.

7. Post-Market Surveillance: After approval or clearance, manufacturers must comply with post-market requirements, including reporting adverse events and maintaining records.

Meeting these requirements is essential for lawful marketing and distribution of medical devices in the U.S. market.

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