M. Elizabeth Bierman

M. Elizabeth Bierman

Morgan Lewis

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Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

8/26/2014 - FDA FDASIA FFDCA Manufacturers Medical Devices

Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key...more

8/6/2014 - FDA Medical Devices Premarket Approval Applications Section 510

FDA Releases Details of New Framework for Laboratory Developed Tests Regulation

FDA sends notice to Congress on LDTs. The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a risk-based, phased-in framework for oversight of laboratory...more

8/1/2014 - Draft Guidance FDA Laboratory Developed Tests Manufacturers Medical Devices

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

7/23/2014 - Draft Guidance FDA Final Guidance Healthcare Manufacturers Marketing Medical Devices Unique Device Identifiers

FDA to Cease Active Regulation of MDDS and Other Health IT Devices

The draft guidance also enables some health IT manufacturers to avoid the device tax. The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more

6/24/2014 - FDA Health Information Technologies Healthcare Medical Devices Mobile Devices

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

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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