5. Device Description We recommend that you identify your device by regulation and product code described in Section 4. Scope, and include the following information: • indications for use • design features; i.e., materials, configurations, size, safety features • specifications and dimensions • materials, including chemical formulation • conformance with standards.
Side by side comparisons of the information described below, whenever possible, in tabular format are desirable. We recommend that you describe how any differences may affect the comparative safety and effectiveness of the new device.