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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry  Food and Drug Administration (FDA) Final
Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third Parties   Food and Drug Administration (FDA) Final
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
CPG Sec 567.100 Antipasto, Common or Usual Name  Food and Drug Administration (FDA) Final
CPG Sec 525.400 Hollandaise Sauce - Common or Usual Name  Food and Drug Administration (FDA) Final
Recommended Methods for Blood Grouping Reagents Evaluation: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CPG Sec 560.450 Imported Low-Acid Canned Foods (Manufacturer Not Registered and/or No Scheduled Process Filed)  Food and Drug Administration (FDA) Final
Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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