Classification and Special Controls for Posterior Cervical Screw Systems
This guidance explains the classification of posterior cervical screw systems as Class II medical devices with special controls, following FDA's final rule published on April 1, 2019. It is specifically designed to help small entities comply with the requirements established in 21 CFR 888.3075.
Recommended Actions
- Review the classification regulation 21 CFR 888.3075 to understand the device identification and special controls
- For new devices, ensure compliance with all special controls before submitting a 510(k)
- For existing devices on the market before May 1, 2019, document compliance with special controls but no new submissions are required
- Monitor any updates to the classification regulation through the electronic Code of Federal Regulations (eCFR)
- Maintain documentation demonstrating compliance with special controls for regulatory inspections
Key Considerations
Other considerations
- Devices must comply with special controls as defined in 21 CFR 888.3075
- Manufacturers of devices already on the market as of May 1, 2019, do not need to submit new 510(k)s, 510(k) amendments, or add-to-files to demonstrate conformance with the special controls
- The classification regulation became effective May 1, 2019
Related references and norms
- 21 CFR 888.3075: Classification regulation for posterior cervical screw systems
Original guidance
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