FDA Regulation of Medical Devices and In Vitro Diagnositcs (IVDs)

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Medical Device and In Vitro Diagnostics (IVDs) -- Presentations

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MDUFMA – A Review of Key Provisions. OCRA Program on MDUFMA,
December 2002, Irvine, CA.

Medical Device and In Vitro Diagnostics (IVDs) -- Articles

The “De Novo” 510(k) Process and the Reclassification of Class III Devices.
Edited Transcript of Presentation of Michael A. Swit, Esq., at the November 2001
Breakfast Briefing on Current FDA Issues. San Diego, California.

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