Morgan Lewis

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03/27/14 Medical Device Update: FDA Issues Proposed Regulations on Medical Device Classification and Reclassification to Streamline the Process
The Food and Drug Administration (FDA) issued proposed regulations on March 25, 2014 to implement Food and Drug Administration Safety and Innovation Act (FDASIA) provisions enacted in July 2012 on medical device classification and reclassification.
03/12/14 Medical Device Update: FDA Releases Final Pre-Submission Guidance
The new guidance includes requirements on the type, timing, format, and content of requests for feedback meetings and telephone conferences with FDA. Therefore, it will be important for the medical device industry to be aware of these requirements in planning their device development activities and timelines.
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Related News

10/03/13 Morgan Lewis Receives 2013 LMG Life Sciences Awards
Morgan Lewis was named Healthcare Pricing and Reimbursement Firm of the Year at the inaugural LMG Life Sciences awards ceremony.
08/27/13 Nestle, Dannon, Gerber Beat Baby Product Fluoride Suit, Law360
Morgan Lewis's representation of Dannon is covered.
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

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

31 Publications Found
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Date Title Publication
04/08/1404/08/14 Health IT Update: FDASIA Health IT Report Issued by FDA, FCC, and ONC

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Health IT Update
03/27/1403/27/14 Medical Device Update: FDA Issues Proposed Regulations on Medical Device Classification and Reclassification to Streamline the Process

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Health IT Update
03/12/1403/12/14 Medical Device Update: FDA Releases Final Pre-Submission Guidance

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Health IT Update
03/03/1403/03/14 March 2014 Medical Device Update

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Health IT Update
02/14/1402/14/14 FDA Warning Letters Signal Narrowing of “Medical Food” Category

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Food Industry LawFlash
10/28/1310/28/13 October 2013 Update: Software and Mobile Medical Apps Regulation

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Health IT Update
10/09/1310/09/13 Mobile Medical Applications: FDA’s Final Guidance

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Webinar
09/25/1309/25/13 FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications

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Life Sciences and Healthcare LawFlash
08/20/13August 2013 FDA Efforts to Balance Health IT Innovation and Safety, LMG Life Sciences

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Article
07/15/1307/15/13 FDA Issues New Medical Device Reporting Guidance

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Life Sciences and Healthcare LawFlash
06/17/1306/17/13 FDA Taking on Cybersecurity Risks for Medical Devices

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Life Sciences and Healthcare LawFlash
06/10/1306/10/13 June 2013 Update: Software and Mobile Medical Apps Regulation

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Health IT Update
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
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