News & Analysis as of

Medical Devices

FDA Requires Reprocessing Validation Data for Certain Reusable Devices

by Hogan Lovells on

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated...more

What does Brexit mean for life sciences companies in the EU and UK?

by Hogan Lovells on

Life sciences companies in both the EU and the UK are beginning to speculate on what Brexit will mean for business. In this video, Elisabethann Wright, partner, and Jane Summerfield, counsel, in our European Life Sciences...more

MedPAC Takes Anti-POD Stance in Report to Congress, Echoing an Increasingly Uniform Consensus

by Ropes & Gray LLP on

On June 15, 2017, the Medicare Payment Advisory Commission (MedPAC), a non-partisan group that advises Congress on Medicare policy, released its annual Report to the Congress on Medicare and the Health Care Delivery System...more

FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework

by Ropes & Gray LLP on

In his first public statement as Commissioner of the Food and Drug Administration (“FDA”) on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes. In a...more

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

by Hogan Lovells on

Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more

New Jersey Stryker LFit V40 Lawsuits Receive Consolidation

On August 29, 2016, Stryker issued a voluntary recall of certain lots of Stryker LFit Anatomic Cobalt Chromium V40 femoral heads, a prosthetic hip replacement device, manufactured before March 2011. This recall included over...more

Medtronic's Recent Interactions with the FDA

by Knobbe Martens on

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

FDA Approves Bayer’s myBETAapp™

by Knobbe Martens on

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the...more

House Energy & Commerce Committee Unanimously Approves FDA Reauthorization, Public Health Bills

by Reed Smith on

On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device,...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

Health Alert (Australia) 12 June 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 7 June 2017 - Al Muderis v Duncan (No 3) [2017] NSWSC 726 - DEFAMATION – assessment of damage – highly respected orthopaedic...more

JPML Hears Physiomesh Centralization Motion

The U.S. Judicial Panel on Multidistrict Litigation (“JPML” or “The Panel”) is a body of seven federal district judges who manage multidistrict litigation, meeting on a bimonthly basis to consider requests to establish MDLs....more

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems

by Knobbe Martens on

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017. The report recommends various protective actions for hospitals to take and points to...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

FDA Extends Unique Device Identification (UDI) System Compliance Deadlines for Certain Low-Risk Medical Devices

by McDermott Will & Emery on

In Depth - On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique device...more

As FDA Ramps Up Digital Health Program, BakerHostetler Hosts a Medical Device Connectivity Webinar Addressing Digital Technology...

by BakerHostetler on

Recent reports indicate that Food and Drug Administration (FDA) plans to build a digital health unit within and assign a number of digital scientists to the Center for Devices and Radiological Health. The digital health unit...more

Eighth Circuit Court of Appeals Affirms Dismissal of TCPA Claims on Grounds of Prior Express Consent

by Stinson Leonard Street on

In Zean v. Fairview Health Services, the U.S. Court of Appeals for the Eighth Circuit recently affirmed the district court's dismissal of a putative class action complaint under the Telephone Consumer Protection Act (TCPA)....more

Effective Immediately: The FDA Updates Humanitarian Device Exemption Regulations

by Faegre Baker Daniels on

On June 7, the U.S. Food & Drug Administration (FDA) announced that it is updating the humanitarian device exemption (HDE) regulations. The changes are meant to bring the regulations into compliance with the 21st Century...more

FDA Extends the UDI Compliance Date for Certain Class I and Unclassified Devices

With the deadline for compliance with the unique device identification system[i] (UDI system) requirements for certain Cass I and unclassified devices other than implantable, life-supporting, or life-sustaining devices (i.e.,...more

HHS Task Force Says Healthcare Cybersecurity is in “Critical Condition”

Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry’s cybersecurity challenges. That Task Force–a combination of public and private...more

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more

Filling in the Gaps on Medical Device Cybersecurity

by Hogan Lovells on

Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...more

Can Robot-Assisted Surgery Be a Pain?

Recently, my colleague Amy Foust made some really good points about a subject that is rarely discussed. Over the years, a number of patients have claimed that they were injured by surgical robots defective by design or...more

FDA Uses Real-World Evidence to Approve a Transcatheter Heart Valve

by Mark Mansour on

From news accounts on June 5, 2017 - The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure...more

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