Morgan Lewis

Related Publications

12/11/12 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.
06/29/12 What Is the Device Industry Getting for Its Money?
FDA user fee reauthorization legislation seeks to ease premarket regulatory burdens, but increases postmarket scrutiny.
08/09/11 FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications
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Related News

07/13/11 Morgan Lewis Team Advises Kinetic Concepts on Company’s $6.3 Billion Acquisition by Apax
Morgan Lewis advised Kinetic Concepts, Inc. (KCI), on a definitive merger agreement under which a consortium comprised of private equity funds will acquire KCI in a $6.3 billion transaction.
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M. Elizabeth Bierman

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Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5206
Fax: 202.739.3001

19 Publications Found
Date Title Publication
12/11/1212/11/12 IRS Issues Device Tax Regulations; Industry Braces for 2013 Implementation

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Cross-Practice Alert
06/29/1206/29/12 What Is the Device Industry Getting for Its Money?

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Life Sciences and Healthcare LawFlash
08/09/1108/09/11 FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

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Life Sciences and Healthcare LawFlash
07/28/1107/28/11 New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions

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Life Sciences and Healthcare LawFlash
05/23/11May/June 2011 FDA Issues Final Rule for Medical Device Data Systems, Classifying Certain Health IT Products, FDLI Update

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Article
02/15/1102/15/11 New FDA Rule on Data Systems Has Implications for Device Manufacturers, Health IT Developers, and Healthcare Providers

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FDA and Healthcare LawFlash
01/19/1101/19/11 FDA Preserves 510(k) Pathway; Announces Initial Modifications in Reform Program

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FDA and Healthcare LawFlash
12/03/1012/03/10 IRS Requests Comments on New Medical Device Excise Tax

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FDA and Healthcare LawFlash
08/13/1008/13/10 FDA Issues Recommendations on 510(k) Reform and Use of Science in Regulatory Decision Making

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FDA and Healthcare LawFlash
04/13/1004/13/10 Healthcare Reform Law Imposes New Tax and Other Requirements for Device Manufacturers

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Washington Government Relations and Public Policy LawFlash
05/29/09May/June 2009 State Regulation of Medical Device Distribution: Strategic Planning Needed to Address Varying Requirements, FDLI Update

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Article
05/01/09May 2009 FDA and Health IT—As Role of Health IT Gains New Significance, Regulators Will Be Keeping Watch, Health Law Analysis

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Article
05/30/08May/June 2008 Computer and Software Devices: FDA Seeks Framework for Regulation, FDLI's Update

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Article
04/25/0804/25/08 Regulatory Process—Navigating the FDA: Moving from Product Concept to Product Clearance/Approval, presented at Morgan Lewis and Pittsburgh Life Sciences' Spring Training Briefing Series, Pittsburgh


 Speech
04/17/0704/17/07 Managing Customer Communications in a Post-Neurontin World, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.


 Speech
01/01/9601/01/96 Impact of the Lobbying Disclosure Act of 1995 On Trade Associations

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White Paper
12/01/9512/01/95 The Lobbying Disclosure Act of 1995

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White Paper
08/01/9208/01/92 Environmental Marketing Claims: ML&B White Paper

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White Paper
08/01/90August 1990 Product Liability Considerations Applicable To Pharmaceuticals Marketed In The United States, Legal Mind (Japan), Vol. 78


 Article