Morgan Lewis

Related Publications

08/25/14 Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process
The draft provides guidance on a streamlined process for submitting requests to the FDA to down-classify certain low-to-moderate-risk devices that have been automatically classified as Class III.
08/06/14 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 changes to FDA’s policies that may affect their 510(k) submissions, including new limitations on the use of multiple predicates, the unacceptability of split predicates, an increase in the content and detail required for 510(k) summaries, and FDA’s intent to “verify the accuracy and completeness” of 510(k) summaries.
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Related News

09/29/14 LMG Life Sciences Praises Morgan Lewis’s Life Sciences Capabilities
Morgan Lewis announces that the firm’s strength in the life sciences industry has been recognized on numerous occasions recently in the Legal Media Group’s LMG Life Sciences 2014 legal guides.
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.
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M. Elizabeth Bierman

Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
United States of America
Phone: +1.202.739.5206
Fax: +1.202.739.3001

34 Publications Found
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Date Title Publication
09/26/1409/26/14 BIO IP & Diagnostics Symposium (BIO IPDX) Conference


Speech
08/25/1408/25/14 Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

pdf View LawFlash
Health IT Update
08/06/1408/06/14 Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

pdf View Update
Medical Device Update
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
05/01/14May 2014 FDA Regulation of Wearable Medical Technology: It’s Not Just a Mobile Medical App, Health Lawyers Weekly

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Article
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
09/24/1309/24/13 Q&A on Medical Device Reporting Requirements


Webinar
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
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