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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices  Food and Drug Administration (FDA) Final
Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient  Food and Drug Administration (FDA) Final
Guidance for Industry: Determination of Status as a Qualified Facility  Food and Drug Administration (FDA) Final
Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act  Food and Drug Administration (FDA) Final
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF)  Food and Drug Administration (FDA) Final
Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics  Food and Drug Administration (FDA) Final
Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices  Food and Drug Administration (FDA) Final
Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities  Food and Drug Administration (FDA) Final
Hospital Reprocessors: Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use  Food and Drug Administration (FDA) Final
Important Information About Rophae Intraocular Lenses  Food and Drug Administration (FDA) Final
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