Medical Devices

Books & Primers

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...

A Practical Guide to FDA’s Food and Drug Law and Regulation -5th Edition

April 2014

A Practical Guide to Food and Drug Law and Regulation provides a basic introduction to the laws and regulations that govern the developme...

Articles

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...

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...

Can Bayesian Extrapolation Improve FDA Regulation of Off-Label Uses of Drugs and Devices?

June 2014

In this Policy Forum, Authors Ryan Abbott and Ian Ayres explore the issue of extrapolation arising in the regulation of medicine. The aut...

FDLI Names New President and Chief Executive Officer

May 2014

FDLI Names New President and Chief Executive Officer Amy Comstock Rick to lead organization effective August 25th The Food and Drug Law ...

Food & Drug Law Journal

Does Sackett Foreshadow the End of Non-Reviewability for FDA Warning Letters?, 68 Food and Drug Law Journal, 241-258 (2013).

August 2013

FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedur...

Your Business in Court and at Federal Agencies: 2011-2012, 68 Food and Drug Law Journal, 1‑52 (2013).

March 2013

FDA transparency effort continued, including the Secretary’s adopting eight measures to improve access to Agency information and ac...

The Critical Path from Pump to Pancreas: The Impact of FDA Regulation on the Development of a Closed-Loop Diabetes Management System, 68 Food and Drug Law Journal, 53-76 (2013).

March 2013

Breakthrough medical tools and technologies are rapidly becoming available in countries across the world, but cannot be purchased in the ...