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Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff   Food and Drug Administration (FDA) Final
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff   Food and Drug Administration (FDA) Final
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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