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.
What You Need to Know? 👇
What is the FDA classification for posterior cervical screw systems?
Posterior cervical screw systems are classified as Class II medical devices with special controls under 21 CFR 888.3075, effective May 1, 2019. They have product code NKG and require compliance with specific regulatory requirements.
Do existing manufacturers need to submit new 510(k)s for posterior cervical screw systems?
No, manufacturers of devices already on the market as of May 1, 2019, are not expected to submit new 510(k)s, amendments, or add-to-files solely to demonstrate conformance with the special controls.
When did the posterior cervical screw system classification rule become effective?
The classification rule for posterior cervical screw systems became effective on May 1, 2019, following the final rule published in the Federal Register on April 1, 2019.
What regulatory pathway was used before the classification of posterior cervical screw systems?
Prior to classification, FDA regulated posterior cervical screw systems as unclassified preamendments devices requiring premarket notification through the 510(k) pathway for market clearance.
Who requested the classification of posterior cervical screw systems?
The Orthopedic Surgical Manufacturers Association (OSMA) submitted a petition on November 22, 2011, requesting FDA to classify posterior cervical screw systems into Class II with special controls.
What advisory committee reviewed the posterior cervical screw system classification?
The Orthopaedic and Rehabilitation Devices Panel convened on September 21, 2012, to review the classification and recommended that posterior cervical screw systems be classified as Class II with special controls.
What You Need to Do 👇
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