Manufacturers Medical Devices

News & Analysis as of

FDA Issues Draft Guidance on ‘Emerging Signals’

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more

Injunctive Relief Claims Lead to Defense Opportunities

It’s not all that common, but every now and then our opponents feel their oats and seek injunctive relief – usually against the continued marketing of an FDA-approved product. A state-law plaintiff seeking such injunctive...more

Blog: FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers...more

Postmarket Cybersecurity Recommendations for Medical Devices Issued by the FDA

We’ve blogged about medical device cybersecurity topics. The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity...more

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details...more

Food And Drug Administration Issues Draft Guidance On Cybersecurity In Medical Devices

On January 22, 2016, the Food and Drug Administration (“FDA”) released draft guidance regarding postmarket management of cybersecurity risks in medial devices. This guidance comes over a year after the FDA issued similar...more

FDA applies postmarketing requirements to evolving medical device cyber-risks – key messages to manufacturers

With incursions on cybersecurity occurring daily across a variety of platforms, cybersecurity risks are top of mind for FDA and for the device industry....more

FDA issues guidance on cybersecurity risk management for medical devices

Friday (January 22, 2016), the Food and Drug Administration (FDA) published draft guidance for medical device makers on the importance of including cybersecurity measures in approved products. Further, the guidance highlights...more

FDA Issues Draft Guidance on Postmarket Cybersecurity of Medical Devices

On January 15, 2016, the Food and Drug Administration (“FDA”) released a draft guidance entitled, “Postmarket Management of Cybersecurity in Medical Devices,” outlining recommendations that device manufacturers should...more

Tell Me, Tell Me, Where I’m Going: Recent FDA Presentation Offers a Crystal Ball Into Medical Device Inspectional Priorities and...

In this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band...more

China's Medical Device Market: New Policies, Higher Stakes

The recent introduction of the Regulations on the Supervision and Administration of Medical Devices (also known as State Council Order 650) has created significant impact in the medical device industry in China. The changes...more

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

Bad News from Europe for Makers of Life-Saving Medical Devices

In over eight years, we’ve never before blogged about a European development in prescription medical product liability. The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston...more

Medicinal Product Regulation and Product Liability in Australia: Overview

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

The Internet of Things

In this Presentation: - Internet of Things - definition - But what is it all about? - But not just that... - The IoT market in figures... - Beecham Research - view of the World - The Connected...more

OIG Advisory Opinion Approves Patient Subsidies For Clinical Study

On June 4, 2015, OIG published an advisory opinion (No. 15-07) stating that it will not impose administrative sanctions on a medical device manufacturer that planned to pay for copayments and certain other costs for Medicare...more

3D Printing, Innovation Protection, and Manufacturing: The Big Change is Now

Intellectual property (IP) law is undergoing a major transformation just as additive manufacturing? or 3D printing? has begun to revolutionize the manufacturing industry. The interplay between these two forces could end up...more

New Requirements Regarding Emergency Alert Access Imposed On Device Manufacturers And MVPDs

On May 28, 2015, the FCC released a Second Report and Order and Second Further Notice of Proposed Rulemaking pursuant to authority granted by the Twenty-First Century Communications and Video Accessibility Act of 2010 (CVAA)...more

CMS Releases Latest Medicare Hospital and Physician Utilization, Payment Data

CMS has released detailed Medicare inpatient hospital, outpatient hospital, and physician utilization and payment data for 2013, including data analysis such as spending breakdowns by specialty and region. The hospital data...more

Adopting a Safety Policy and Assembling a Safety Team

Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand,...more

FDA launches medical device database: AccessGUDID

On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and...more

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more

Tenth Circuit affirms federal preemption of state law tort claims for medical devices

In Caplinger v. Medtronic, __ F.3d __ (10th Cir. 2015), the Tenth Circuit Court of Appeals affirmed dismissal of a patient’s state law tort claims against a medical device manufacturer as preempted by federal law. The Tenth...more

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