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HHS Guidance Submissions

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Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise Equipment  Food and Drug Administration (FDA) Final
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices  Food and Drug Administration (FDA) Final
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles  Food and Drug Administration (FDA) Final
Guidance for Dermabrasion Devices - Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Model Accreditation Standards for Third-Party Certification Body Accreditation for Food Safety Audits  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls  Food and Drug Administration (FDA) Final
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