Medical Devices

News & Analysis as of

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more

China FDA Releases Guideline for Medical Device Registration Studies

On May 19, 2015, the China Food and Drug Administration (“CFDA”) unveiled the Technical Guideline Governing Medical Device Clinical Evaluation (“Guideline”). The long-awaited Guideline explains the methodology for clinical...more

Health Care Update - May 2015 #3

In This Issue: - 21st Century Cures Markup; Full Committee to Take Up this Week - Senate Finance Committee Solicits Health Bills for Upcoming Markup - Implementation of the Affordable Care Act - Federal...more

Medical Device Tax Repeal Heating Up

Following up on the hearing from B. Braun Medical Inc. advocating for the repeal of the medical device tax, according to news sources, more than a dozen House Democrats are pressuring leadership to advance a bill repealing...more

Ontario Superior Court States Clear Rule on Pre-Certification Production of Medical Records in Class Actions

On March 20, 2015, Justice Belobaba released his reasons in Dine v Biomet, a motion concerning the production of medical records prior to a certification motion. The case is a proposed product liability class action...more

Washington Healthcare Update

This Week: Health Subcommittee Advances 21st Century Cures, Full Committee Action Scheduled…Senate Finance Committee Hearing: Chair Hatch to Launch New Initiative on Improving Chronic Care for Medicare Patients…Hawaii’s...more

“After” What? Subsequent Remedial Measures Excluded In Zimmer Evidentiary Win

Last weekend, we celebrated Mother’s Day. As we contemplated the text message and the Tufts University mug we received from the Drug and Device Rock Climber, it occurred to us that we could hardly remember a time before that...more

FDA Issues Guidance for Mobile Medical Apps

Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act...more

Time and Preemption

The time for Mad Men is almost over. Next Sunday is the finale, and we can hardly stand the thought that our tv screens will no longer harbor Don Draper, his predatory, boozing advertising colleagues, his aggrieved family,...more

Guest Post - Product Liability Cases Are No Longer Quintessential Class Actions In Ontario

What follows is a guest post about a recent favorable development in Canadian drug/device litigation. We're not Canadian lawyers, so we gladly outsource Canadian developments to those who are, such as these guys - Mike A....more

St. Jude Medical Acquires Spinal Modulation, Inc.

St. Jude Medical recently announced that it has completed the acquisition of Spinal Modulation, Inc.  In June of 2013, St. Jude invested $40 million in Spinal Modulation for which it received an exclusive option (now...more

Connecticut Legislature Reduces Mandatory Reporting of Payments to APRNs

On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more

FDA Initiates Expedited Access Pathway Program for Medical Devices via Final Guidance Document

The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more

Globus Argues Expert’s Faked Credentials Warrants New Trial

In 2011, DePuy-Synthes, a subsidiary of Johnson & Johnson Inc. sued Globus Medical, Inc. in the United States District Court for the District of Delaware. In that suit, Synthes alleged that Globus had infringed three Synthes...more

New state law allows access to investigational drugs

In line with a nationwide movement, on April 21, 2015, Governor Fallin signed into law House Bill 1074, the Oklahoma Right to Try Act. The Act allows physicians to prescribe to terminally ill patients investigational drugs,...more

Medical Innovation: Congressional Committees Support Accelerated Research and Development for New Drugs, Devices and Biologics

Recent hearings by Senate and House committees and a scheduled markup underscore Congress' continued commitment to eliminating barriers that are slowing the development of effective drugs, devices, and biologics so that...more

USPTO Medical Device Technology Fair

The United States Patent and Trademark Office (“USPTO”) is hosting a Medical Tech Fair & Medical Device Partnership Meeting on June 2-3, 2015....more

Healthcare & Life Sciences Private Equity Deal Tracker: Moximed Secures $33 Million in Financing

Moximed, based in Hayward, Calif., is focused on developing minimally invasive, joint preserving solutions for patients with knee osteoarthritis....more

FDA Regulatory and Compliance Monthly Recap – April 2015

In This Issue: - FDA issues guidance documents on how it considers balancing premarket and postmarket data collection during PMA reviews in a bid to accelerate the approval of new breakthrough devices - Guidance...more

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

Changes to the regulation of pharmaceutical business in Kazakhstan: implications for pharmaceutical companies

A significant number of amendments have been introduced to the Healthcare Code* of the Republic of Kazakhstan on 6 April 2015 by the adoption of the Law On Introduction of Amendments and Additions to Certain Legal Acts of the...more

Blog: Connecticut Delays Payment Reporting Until 2017

Under a Connecticut law enacted in 2014, pharmaceutical and medical device manufacturers were required to begin reporting payments made to advanced practice registered nurses (APRNs) on July 1, 2015. ...more

Health Care Update - May 2015

In This Issue: - House Energy and Commerce Continues 21st Century Cures Progress - Pioneer ACO Program to be Expanded - Federal Regulatory Initiatives - Congressional Initiatives - Other Health Care...more

Lost Profits Are Hard to Come By - Warsaw Orthopedic, Inc. et al. v. NuVasive, Inc.

Addressing the issue of convoyed and related sales, the U.S. Court of Appeals for the Federal Circuit, even while affirming the district court with respect to its invalidity and infringement findings, remanded the case for a...more

3D Printing Medical Devices

The recent news that certain Lowe’s stores will offer customers the ability to custom-make 3D printed items has garnered a lot of attention. But perhaps even more exciting is that 3D printing (also known as additive...more

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