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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Reprocessing and Reuse of Single-Use Devices : Guidance for Industry and FDA Reviewers  Food and Drug Administration (FDA) Final
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
510(k) Submissions for Coagulation Instruments: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Application User Fees for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
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