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  6. Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures; Proposed Rule; Preliminary Regulatory Impact Analysis
  1. Economic Impact Analyses of FDA Regulations

Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures; Proposed Rule; Preliminary Regulatory Impact Analysis

This proposed rule, if finalized would classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a premarket approval application. We did not identify economic benefits for this proposed rule. The costs of the rule include one-time costs associated with reading the proposed rule.

Regulatory Impact Analysis

Regulatory Impact Analysis of FDA proposed rule Classification of Spinal Spheres (PDF 204 KB)

Federal Register: 86 FR 71191

Docket: FDA-2021-N-0310

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