Columns & Articles


510(k) Substantial Equivalence In Plain English - Part 1   PDF [Part 2 will be out in two weeks.]

Listen to the podcast Simplifying Substantial Equivalence In FDA Premarket Notifications

Sept. 12, 2014

Biomedical nanotechnology: The smaller the thing, the bigger the challenge (HealthCare Packaging)   PDF Aug. 25, 2014

Everything You Know about Materials Is Wrong (Qmed)   PDF

Aug. 15, 2014
Panel discusses legal, ethical concerns of 3D printing (American Bar Association Annual Meeting)   PDF Aug. 8, 2014

Is Your Boring Regulatory Strategy Costing You Business  PDF

Aug. 2014

Guerilla Regulatory Strategy (MED Device Online Regular Contributor)

Take Control Of Your Medical Device's FDA Classification (MED Device Online)    PDF

Jul. 2, 2014
How to Sharpen Your Regulatory Sword   (MDDI)     PDF Feb. 11, 2014
3 Tips To Vastly Improve Your FDA Communication Strategy    (MDDI)     PDF May, 2, 2014


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