Morgan Lewis

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07/22/14 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 analyzed some of the more significant guidances that were issued in the second quarter of 2014 (April–June).
06/24/14 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The draft guidance also enables some health IT manufacturers to avoid the device tax.
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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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29 Publications Found
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Date Title Publication
07/31/1407/31/14 FDA Releases Details of New Framework for Laboratory Developed Tests Regulation

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Life Sciences and Healthcare LawFlash
07/22/1407/22/14 Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

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Health IT Update
06/24/1406/24/14 FDA to Cease Active Regulation of MDDS and Other Health IT Devices

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Health IT Update
05/22/1405/22/14 FDA’s New Device Reclassification Process: How New Criteria May Impact Your Device

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Webinar
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
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