Tag Archives: medical device manufacturers

Reed Smith’s Kevin Madagan and Julia Lake to Present an Advertising and Promotion Primer at DIA’s Regulatory Affairs Conference

Reed Smith partner Kevin Madagan and associate Julia Lake will return for a second year to help lead a four-hour “Ad Promo Primer” at the Drug Information Association (DIA)’s “Advertising and Promotion Regulatory Affairs Conference,” which will be held virtually May 18-20, 2020. In addition, Kevin, a member of this year’s planning committee, will be leading … Continue Reading

Reed Smith White Paper on Major Health Care Policy, Funding Provisions in CARES Act

The United States recently passed the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act), sweeping legislation that could impact pharmaceutical and medical device companies with U.S. operations or significant U.S. sales. A team of Reed Smith life sciences and health care lawyers, including Scot T. Hasselman, Robert J. Hill, Carol Colborn Loepere, Kevin M. Madagan, Paul W. Pitts, James … Continue Reading

Medical Device Manufacturers Could Be Affected by Recent CMS Guidance to Health Care Providers

Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures outside of the United States, should be aware of recent guidance the U.S. Centers for Medicare and Medicaid Services (CMS) issued to health care providers urging limitations on elective surgeries and nonessential procedures. As an … Continue Reading

AdvaMed Issues Revised Code of Ethics on Interactions with U.S. Health Care Professionals

The Advanced Medical Technology Association (AdvaMed) – the national industry association of medical technology manufacturers – recently issued an updated Code of Ethics on Interactions with Health Care Professionals (HCPs) (the AdvaMed Code or Code). Last revised in 2009, AdvaMed’s updated Code will go into effect January 1, 2020. The Code speaks to the evolving … Continue Reading

Join Us: Life Sciences Health Industry Roundtable on “Identifying and Mitigating Risk in a Changing Global Economy”

In-house counsel at pharmaceutical, medical device, and health companies are invited to join their peers and leading Reed Smith life sciences lawyers for a roundtable discussion on how to identify and mitigate risk. The event will be held on 5 March in Reed Smith’s London office. A networking breakfast will be provided at 8:30 a.m., … Continue Reading

Major Medical Device Changes In China Introduced by the 2018 Draft Amendment to the “Regulations on the Supervision and Administration of Medical Device”*

Following the issuance of the “Opinions on Deepening the Reform of Examination and Approval System and Encouraging Innovation in the Industries of Pharmaceuticals and Medical Devices” by the Central Office of the Communist Party of China and the Office of the State Council on October 1, 2017, the former China Food and Drug Administration** formulated … Continue Reading

Little-Known Trap in U.K. Intellectual Property Litigation Could Cost Successful Plaintiffs: What Life Sciences Companies Need to Know

Did you know the U.K. patents system penalizes a failure to record a patent transaction at the Patent Office by depriving a successful plaintiff of its entitlement to recover its full legal costs in any subsequent infringement litigation on that patent? It’s a little-known trap for the unwary, and the subject of our London partner … Continue Reading

Upcoming Free Educational Opportunities for Life Sciences Clients

As the life sciences industry continues to undergo significant changes, Reed Smith is committed to offering high quality, free educational opportunities for its pharmaceutical, medical device, and biotechnology clients. We thus are pleased to shared two upcoming opportunities with you. First, because the new import tariffs proposed by the current administration could significantly affect life … Continue Reading

FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also assuring the safety of the devices throughout their Total Product Life Cycle (TPLC). To that end, FDA intends to focus … Continue Reading

Upcoming Free Ethics CLE Webinar: “Privilege Protection: Tips for Working with Media Consultants Without Jeopardizing the Attorney-Client Privilege”

Involving any outside consultant in the attorney-client relationship gives rise to risks to the attorney-client privilege. Yet when a PR crisis erupts, good communications advice is essential, and a company’s media strategy can determine whether it is the subject of thoughtful, balanced articles or a maelstrom of misleading headlines – and whether unfair publicity infects … Continue Reading

Upcoming Free CLE Webinar: “Multidistrict Litigation: What to Expect from JPML Consolidation Through Trial”

With more than half of all cases pending in the federal courts now docketed in multidistrict litigations (MDLs), pharmaceutical and medical device companies facing large-scale litigation should expect to find themselves before the Judicial Panel on Multidistrict Litigation (JPML) with an MDL on the horizon. That’s why Melissa Geist and Jennifer Eppensteiner are pleased to … Continue Reading

FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to present an … Continue Reading

Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances

On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a … Continue Reading

Senate Bill Seeks to Provide “Floor” for Cybersecurity Operational Standards for Internet-Connected Devices Purchased by Federal Agencies

A recent bill introduced by Sen. Mark Warner (D-Va.) is attempting to place heightened security standards on all Internet of Things (IoT) devices procured by any federal agency. Should the legislation be enacted, the expectations it sets forth regarding the security of IoT devices could be interpreted by courts as the minimal floor for any … Continue Reading

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff,” which was published in the Federal Register. This guidance was previously circulated in May 2016 in a draft form and underwent a comment period, where … Continue Reading

Upcoming Free CLE Webinar: Hosting and Managing User Generated Content (UGC)

Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “Hosting and Managing User Generated Content (UGC)” on Thursday, January 19, 2017 at 12 p.m. ET. This webinar will address the legal liability and responsibility of a drug or device company that incorporating any user generated content (UGC) features on websites … Continue Reading

Join Us for a Free CLE Webinar on Social Media Issues for Pharmaceutical, Medical Device Companies

The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Social Media Issues for Pharmaceutical and Medical Device Companies,” on November 2, 2016 at 12 p.m. ET. Social media can be a great way to engage with consumers and build your brand. For pharmaceutical and medical device companies, however, it … Continue Reading

Reed Smith Attorneys to Speak at DRI’s November 10th Government Enforcement and Corporate Compliance Seminar

Reed Smith attorneys Jason Casell and Steve Miller will be moderating and presenting respectively on the “Pharmaceutical and Medical Devices Industries Update” panel on November 10, 2016 at DRI’s Government Enforcement and Corporate Compliance Seminar. This panel will examine recent government enforcement activities and legal decisions that might shape investigations, litigation, and resolutions of government … Continue Reading

Please Join Us For A Reed Smith Webinar On 3D Printing – Will Regulatory Pathways and Reimbursement Change?

The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Think Differently. 3D Printing – Will Regulatory Pathways and Reimbursement Change?” on July 21 , 2016 at 12:00 p.m. ET. Reed Smith presenters Gail Daubert, Celeste Letourneau and Kevin Madagan will be discussing the increasing popularity of 3D printing and … Continue Reading

Reed Smith Attorneys to Present AdvaMed Webinar on “Top 10 Product Liability Issues”

Michael Brown and Lisa Baird from our Life Sciences Health Industry Team will be presenting an hour-long AdvaMed Medical Technology Learning Institute webinar on “Top 10 Product Liability Issues” on July 20 at 1 p.m. ET. Product liability litigation is ever-evolving, and the plaintiffs’ bar is continually adapting its business model and litigation strategy against … Continue Reading

New Edition of Singapore International Arbitration Centre Rules to Come into Effect Shortly

Pharmaceutical and medical device manufacturers are increasingly finding themselves resolving disputes through international arbitration. After London, Singapore is now arguably the second most important arbitration center in the world, meaning the Singapore International Arbitration Centre’s (SIAC) new arbitration rules, which were due to come into effect on June 1, 2016, but will now come into … Continue Reading
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