FDA Overview of the Process for Clearance and Approval of ...

FDA Overview of the Process for Clearance and Approval of Mass Spectrometry-based In vitro Diagnostic Devices

MSACL January 23rd, 2018

Doug Jeffery, Majda Haznadar, Matt Humbard

doug.jeffery@fda. majda.haznadar@fda. matthew.humbard@fda.

Disclaimer

This presentation is intended for informational purposes only and does not constitute legal or regulatory advice. Please see the Federal Food, Drug, and Cosmetic Act and 21 CFR Subchapter H

for a full list of requirements by FDA

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Disclosures

We have no financial conflicts to disclose

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Talk One: Overview (Doug)

1. Goals of this Short Course 2. FDA Organizational Structure 3. Primer on In Vitro Diagnostics (IVDs) 4. How Submissions are Reviewed

? Talk Two: Pre-Submissions (Majda)

? Talk Three: Investigational Device

Exemptions (Matt)

? Talk Four: 510(k)s, De Novos, and the

Sciex Vitamin D 200M Assay for the

Topaz System (Matt)



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Goals of This Short Course

1. Have fun! 2. Be interactive! 3. Introduce ourselves 4. Tell you about the role FDA plays in providing

essential diagnostic medical devices to patients in the U.S.



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