Productos combinados
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Combination Product Definition - What is a Combination Product? Read the FDA's definition now.
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Combination Product Definition
Combination Products Topics
About Combination Products
Combination product definition, reports, examples and common questions.
Classification and Jurisdictional InformationProduct transfers, jurisdictional updates and public RFD decisions.
RFD ProcessRequest for Designation (RFD) submission information.
Guidance & Regulatory Information
Combination products rules, regulations, and guidance documents.
Requests for CommentCombination product documents for public comment.
Meetings, Conferences, & WorkshopsPresentations, articles and information about combination product meetings.
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Key Topics
Combination Products Guidance Documents Guidance for Industry - New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (PDF - 159KB)Postmarking Safety Reporting for Combination Products - Proposed Rule Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 112KB)Classification of Products as Drugs and Devices and Additional Product Classification Issues Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act
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