Consumer Information on: cobas® EGFR Mutation Test v2

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: cobas® EGFR Mutation Test v2PMA…

Consumer Information on: Raindrop® Near Vision Inlay

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Consumer Information on: Juvéderm Volbella® XC

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Family Care Eye Wash by United Exchange Corp: Recall

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MDSAP Invitation

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Posted Ten New MDSAP Education Modules in the “Postmarket Activities” section of CDRH Learn

Premarket Notification (510k) The 510(k) ProgramPresentation    Printable Slides    Transcript Premarket Notification 510(k) OverviewPresentation    Printable Slides 510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)Presentation    Printable Slides 510(k) Third Party ReviewPresentation    Printable Slides 510(k) Electronic Submission Pilot ProgramPrintable Slides   Transcript Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to…