M. Elizabeth Bierman

M. Elizabeth Bierman

Morgan Lewis

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FDA Warning Letters Signal Narrowing of “Medical Food” Category

Manufacturers seeking to enter the medical food market face increased challenges. The Food and Drug Administration (FDA or the Agency) has issued several Warning Letters to manufacturers of medical foods...more

2/17/2014 - FDA Food Manufacturers Food Safety Healthcare

FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

9/26/2013 - FDA Final Guidance Mobile Apps Mobile Devices Telemedicine

FDA Issues New Medical Device Reporting Guidance

Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions. On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more

7/16/2013 - FDA Manufacturers Medical Devices Reporting Requirements

FDA Taking on Cybersecurity Risks for Medical Devices

FDA issues safety communication and draft guidance clarifying that manufacturers are responsible for addressing cybersecurity risks related to their medical devices....more

6/17/2013

IRS Issues Device Tax Regulations; Industry Braces for 2013 Implementation

Pending the January 1 effective date, final regulations and interim guidance on the medical device excise tax provide some clarity but leave many questions unanswered. On December 7, the Internal Revenue Service (IRS)...more

12/12/2012 - Excise Tax IRS Medical Devices

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