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Registration Steps for Class I Medical Devices in the United States
Category：行業(yè)資訊 Date：2024-07-31 17:31:18 Author: Source:
Navigating these registration steps effectively ensures that Class I medical devices meet FDA requirements and are ready for lawful marketing in the United States, contributing to patient safety and public health.

The registration process for Class I medical devices in the United States involves several key steps to ensure compliance with FDA regulations and facilitate market entry:1.jpg

  1. Device Classification: Determine and verify that the device falls under Class I classification, which denotes low risk and less stringent regulatory requirements compared to higher-risk classes.

  2. Establishment Registration: Register the manufacturing facility with the FDA. This step involves submitting Form FDA 2891 to provide essential information about the establishment, including contact details and ownership.

  3. Device Listing: List the device with the FDA using Form FDA 2891. This includes providing details such as device name, intended use, applicable classification, and any predicate device (if applicable).

  4. Quality System Regulation (QSR) Compliance: Ensure compliance with FDA's QSR, outlined in 21 CFR Part 820. QSR covers comprehensive quality management practices, including design controls, production controls, and corrective and preventive actions.

  5. Labeling Requirements: Prepare and review device labeling to ensure compliance with FDA regulations. Labels must include essential information such as device identification, intended use, warnings, and precautions for safe use by healthcare professionals and patients.

  6. Submission of Registration and Listing Information: Submit Form FDA 2891 electronically through the FDA Unified Registration and Listing System (FURLS) or via mail to the FDA's Center for Devices and Radiological Health (CDRH).

  7. Review and Confirmation: The FDA reviews the registration and listing information for accuracy and completeness. If all requirements are met, the FDA issues a confirmation of registration and listing, acknowledging that the device can be marketed in the United States.

  8. Post-Market Responsibilities: After registration, manufacturers must adhere to post-market requirements, such as adverse event reporting, periodic reporting, and compliance with ongoing FDA inspections to ensure continued regulatory compliance.

Navigating these registration steps effectively ensures that Class I medical devices meet FDA requirements and are ready for lawful marketing in the United States, contributing to patient safety and public health.

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