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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Draft Guidance for Industry and FDA Staff   Food and Drug Administration (FDA) Proposed
Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Multiple Function Device Products: Policy and Considerations: Draft Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Proposed
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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