Medical Devices

Books & Primers

Food Law and Regulation, Inspection and Enforcement – an FDLI Primer

June 2015

This primer is designed to be an introduction to food law and regulation. Food law is an ever-growing and ever-changing area of law and r...

Food and Drug Law and Regulation, 3rd Edition

March 2015

Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in ...

The Regulation of Medical Devices in Canada

January 2015

Sara Zborovski, Partner, Davis LLP Andy Radhakant, Partner, Davis LLP Andrew Lord, Associate, Davis LLP Canada’s reg...


Members Only ContentUpdate Magazine March/April 2015

March 2015

Featured Food Labeling Consultations and Modernization in Canada By Martha A. Healey  HIPAA and MOBILE HEALTH APPS: What develop...

Medical Device Color Additives: What’s All the Ruckus About?

January 2015

Volume 5 Issue 1 of the FDLI Policy Forum – Medical Device Color Additives Brenda Seidman, M.S., Ph.D., RAC, Principal, Seidman R...

Members Only ContentUpdate Magazine January / February 2015

January 2015

Table of Contents Featured Risky Business – On the Trial of Tainted Dietary Supplements by Jason Humbert  Between Two Ev...

Should FDA Assume Sole Enforcement Responsibility for Alleged Violations of the FDCA? Lessons from Recent Medical Device Enforcement and Qui Tam Cases

November 2014

Volume 4 Issue 11 of the FDLI Policy Forum – Medical Device Enforcement Actions  Issue 11 of the FDLI Food and Drug Policy For...

Food & Drug Law Journal

Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA, 70 Food and Drug Law Journal 187–207 (2015)

January 2015

The Supreme Court’s decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a &ldq...

The End of “Patent Medicines”? Thoughts on the Rise of Regulatory Exclusivities, 70 Food and Drug Law Journal 39–54 (2015)

January 2015

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown...

Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu’s “Scout,” 70 Food and Drug Law Journal 209–235 (2015)

January 2015

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come int...