FDAnews Device Daily Bulletin

FDA UPDATES GUIDANCE ON REAL-TIME PMA SUPPLEMENTS

May 12, 2006
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The FDA has updated its guidance for real-time premarket approval application (PMA) supplements. The original document was issued April 28.

The guidance provides information about the real-time review process for premarket approval application (PMA) supplements and outlines the procedures for requesting and submitting these types of documents.

The FDA considers a real-time PMA supplement to be appropriate for "a minor change that can be expected within a product line." This includes changes to:Device design;Software;Instructions for use, warnings or precautions or other labeling that does not affect the indications or contraindications; andSterilization and packaging methods.

To view the complete guidance, "Real-Time Premarket Approval Application (PMA) Supplements -- Guidance for Industry and FDA Staff," including specific submission requirements and review meeting format, visit http://www.fda.gov/cdrh/ode/guidance/673.pdf (http://www.fda.gov/cdrh/ode/guidance/673.pdf).