Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff

Issue Date: May 4, 2020
Issued by: Center for Devices and Radiological Health
Topic(s): Orthopedic, Premarket Approval (PMA)
Status: Final

Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff

On April 1, 2019, FDA published a final rule in the Federal Register entitled “Classification of Posterior Cervical Screw Systems” (84 FR 12088). This final rule created the classification regulation 21 CFR 888.3075 for posterior cervical screw systems and established special controls. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28) to assist small entities to comply with the requirements established in 21 CFR 888.3075.

Download the Guidance Document