Morgan Lewis

Medical Devices & Radiological Products Publications of Interest

8 Publications Found
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09/28/11 Medical Necessity of Cardiac Implants: The New Enforcement Priority (a West Legal Education webinar)

Presentation | Webinar
Scott Memmott, Albert Shay

06/08/11 Transparency Update: Vermont Revises Disclosure Form and Seeks Comment on 2011 Draft Consolidated Disclosure Guide

LawFlash/Client Alert | FDA and Healthcare LawFlash
Lee Rosebush, Kathleen McDermott, Michele Buenafe

The State of Vermont regulates expenditures and gifts to healthcare professionals and entities by manufacturers of prescribed products (medical device, pharmaceutical, and biological products entities). Such entities with repor... more

06/07/11 The Compliance Revolution Will Be Televised: As Government Turns Up Heat on Healthcare Fraud, OIG Videos Offer Practical Compliance Pointers

LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen McDermott, Arianne Callender

The U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG's) Health Care Fraud Prevention and Enforcement Action Team (HEAT) has garnered headlines for its coordinated Medicare fraud criminal swee... more

May/June 2011 FDA Issues Final Rule for Medical Device Data Systems, Classifying Certain Health IT Products, FDLI Update

Outside Publication | Article
M. Elizabeth Bierman, Michele Buenafe

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

LawFlash/Client Alert | FDA and Healthcare LawFlash
Phoebe Mounts, M. Elizabeth Bierman

The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) today announced its plan of action for implementation of its 510(k) and science recommendations. The plan of action represents a scali... more

02/24/10 Improving FDA's 510(k) Review Process

LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

On February 18, the U.S. Food and Drug Administration (FDA or the Agency) held a public meeting titled "Strengthening the Center for Devices and Radiological Health's 510(k) Review Process" to discuss changes to the 510(k) proce... more

02/05/10 Rising Regulatory and Congressional Scrutiny of Facilities Using Radiation-Emitting Devices

LawFlash/Client Alert | Cross-Practice Alert
Energy and FDA & Healthcare Practices

The New York Times recently published a series of articles that highlighted medical issues associated with excessive or incorrect radiation exposures in therapeutic applications. The articles suggest that, in many cases, the ... more

October/November 2005 Manufacturing Outsourcing in the Medical Device Industry: An Overview of the Process and Key Legal Issues, Morgan Lewis on Life Sciences
October/November 2005

Newsletter | Article
Barbara Melby

In today’s increasingly competitive global economy, medical device companies are continually seeking ways to drive down production costs while at the same time improve quality and accelerate time-to market. Outsourcing the manu... more

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