Publication - 11/22/2013

FDA Final Guidance on Mobile Medical Applications

Life Sciences Now

On September 23, 2013, the FDA issued a guidance (“Final Guidance”) explaining how medical device regulations will be applied to medical mobile applications (MMAs). The Final Guidance provides mobile application manufacturers with recommendations on how to comply with the regulatory and statutory requirements governing medical devices. The Guidance indicates that the FDA intends to limit its enforcement authority to only those mobile applications that operate as medical devices and pose a significant risk to patients if they fail to function as intended.

The Final Guidance outlines three categories of mobile applications (mobile apps) generally: (1) mobile apps that are not medical devices as defined under the Federal Food, Drug, and Cosmetic Act and are therefore not subject to FDA regulation; (2) mobile apps that may meet the definition of a medical device but over which the FDA intends to exercise enforcement discretion because these applications pose a low risk to the public; and (3) mobile apps that meet the definition of a medical device and which the FDA will regulate due to the significant potential risk to patient safety.

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SEC Approves Adjustments to Dollar Amount Tests for Performance Compensations

Investment Management Alert
Kay A. Gordon, Matthew R. Silver

On June 14, 2016, the Securities and Exchange Commission (SEC) issued an Order approving adjustments to the dollar amount thresholds of the asset under management test and the net worth tests used to determine whether a fund investor or a managed account client meets the “qualified client” standard under Rule 205-3 of the Investment Advisers Act of 1940 (the “Advisers Act”).

Worth the Wait: 457(f) Proposed Regulations for Deferred Compensation of Tax-Exempt Organizations

Client Alert
Robert L. Jensen, Christine M. Kong, Lori L. Shannon, Erik D. Vogt

The Internal Revenue Service (IRS) has issued long-anticipated proposed regulations governing Internal Revenue Code (Code) Section 457(f), which applies to nonqualified, unfunded deferred compensation plans or arrangements established by state and local governments and tax-exempt employers.

Funds Receive Auditor Independence Relief From SEC

Investment Management Alert
Carey Bell, Diana E. McCarthy

The staff of the SEC’s Division of Investment Management has provided temporary relief to the fund industry in connection with audit firm independence and Regulation S-X Rule 2-01(c)(1)(ii)(A) known as the “Loan Rule.”

At Long Last: The IRS Issues Proposed Regulations for Deferred Compensation of Tax-Exempt Organizations and State and Local Governments

Client Alert
Christine M. Kong, Lori L. Shannon

The proposed regulations address some of the uncertainties that have perplexed plan sponsors and practitioners for years.

U.S. Department of Education Issues Proposed Borrower Relief Regulations

Client Alert
John R. Przypyszny, Jonathan D. Tarnow

On June 16, 2016, the U.S. Department of Education (the “Department”) published its proposed regulations (the “Proposed Rule”) regarding Borrower Defenses to Repayment (DTR) and related matters.