Frances Emmeline Babb

Frances Emmeline Babb

Morgan Lewis

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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The draft guidance also enables some health IT manufacturers to avoid the device tax. The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more

6/24/2014 - FDA Health Information Technologies Healthcare Medical Devices Mobile Devices

IRS Proposes New Definition of “Political Activity” for Social Welfare Organizations

The initial comment period for the proposed regulations is drawing to a close on February 27, 2014. On November 29, 2013, the Internal Revenue Service (IRS) and the U.S. Department of the Treasury issued a Notice of...more

2/21/2014 - CPRA IRS Social Welfare Organizations

IRS Issues Regulations for Type III Supporting Organizations

Type III supporting organizations should take steps to comply with new regulations and funders should review due diligence procedures for grants made to these organizations. On December 21, 2012, the Internal Revenue...more

1/30/2013 - Charitable Donations IRS Pension Protection Act of 2006 Private Foundations Public Charities Supporting Organizations

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. On December 7, the Internal Revenue Service (IRS)...more

12/12/2012 - Excise Tax IRS Medical Devices

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