Medical Devices

News & Analysis as of

Bundled Discounts Subject to Section 1/Clayton 3 Scrutiny In the Absence of Market Power and Substantial Foreclosure?

Bundled discount programs have received significant antitrust scrutiny over the past decade, even though these marketing programs may benefit both consumers and competition. Typically, bundled discounts have been evaluated as...more

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

Covidien and C.R. Bard Could Be Moving Toward Mesh Settlement

Covidien is not one of the large names associated with pelvic mesh lawsuits. There are 65,000 product liability lawsuits consolidated in a federal court in West Virginia filed by women alleging life-altering complications...more

Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more

CMS Shuts Down Sunshine Act Online Verification Process

On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more

Life Sciences Spotlight - Issue 4, 2014

Since our last edition, there has been a number of developments in the Life Sciences sector across the Asia Pacific region and we are pleased to be able to update you on these recent trends. It is evident that the...more

FDA Takes First Steps Towards Regulating Laboratory Developed Tests

On July 31, the Food and Drug Administration (FDA or “the Agency”) notified Congress that it intends to issue draft guidance proposing a Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (“Draft...more

FDA Releases Long-Awaited LDT Regulatory Framework and Finalizes Companion Diagnostics Guidance

On July 31, 2014, the Food and Drug Administration (FDA) took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices (IVDs). First, FDA released its long-awaited plan...more

FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more

FDA Issues Notice to Congress of Its Intent to Comprehensively Regulate Laboratory Developed Tests (LDTs)

On July 31, 2014, the U.S. Food and Drug Administration (FDA) "pre-published" its proposed new plan to regulate laboratory developed tests (LDTs). In letters to the U.S. Senate and the House of Representatives, the FDA...more

China Unveils Detailed Rules to Implement the Core Device Regulation

The amended Regulation for the Supervision and Administration of Medical Devices (the “Regulation,” also known as the State Council Order No. 650), which came into force on June 1, 2014, set the new framework for China’s...more

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...more

FDA Unveils Anticipated Draft Guidance for the Regulation of Laboratory-Developed Tests

On July 31, 2014, the Food and Drug Administration (FDA) provided Congress notice of its intent to issue draft guidance providing a risk-based framework for the regulation of laboratory developed tests (LDTs) under the...more

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating...more

FDA Releases Draft Guidance To Help Determine Substantial Equivalence for a Device that Has Different Technological...

In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more

Guidance Helps Medical Device Companies Determine Substantial Equivalence

When is a medical device substantially equivalent to another device? Like so much else, it depends. On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to clarify that question....more

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

What’s an MDDS? And Why Should I Care?

Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great...more

FDA Releases Details of New Framework for Laboratory Developed Tests Regulation

FDA sends notice to Congress on LDTs. The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a risk-based, phased-in framework for oversight of laboratory...more

FDA Issues 510(k)/Substantial Equivalence Draft Guidance Describes Benefit-Risk Factors Considered for New 510(k) Devices with...

On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

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