Tag Archives: Medical Devices

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information from devices with patients at the patients’ request. In response to the more active roles patients are playing in their health care, and increased frequency with which patients are seeking … Continue Reading

Upcoming Free CLE Webinar: “The Internet of Things’ Impact on the Health Care Industry: Diagnosing the Dangers with Disruptive Technology”

Reed Smith not only assists our pharmaceutical and medical device clients with their current legal challenges and opportunities, we look around corners to anticipate the next industry disruptor – and to help our clients navigate the legal issues that come with it. For our life sciences clients, the Internet of Things is clearly a game … Continue Reading

Upcoming Free CLE Webinar: “3D Printing: Component Parts/Raw Materials Product Liability & Health Risks”

Reed Smith is at the forefront of thought leadership surrounding 3D printing and how this revolutionary technology will impact our pharmaceutical and medical device clients, as well as universities and other leading medical centers which are incorporating this technology into patient care. Our 3D printing team has authored two white papers (available here and here) … Continue Reading

Upcoming Free CLE Webinar: “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”

The Reed Smith life sciences product liability and 3D printing teams will be hosting an upcoming CLE webinar “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8, 2017 at 12 p.m. ET. Reed Smith presenters Jim Beck and Matt Jacobson will be discussing 3D … Continue Reading

FDA Consumer Update: The 3Rs of 3D Printing – FDA’s Role

On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,”  which reconfirms its position on the importance of 3D printed medical devices.  The FDA sums up its role in this “innovative space” as regulate, research, and resource (i.e., … Continue Reading

Reed Smith Launches Second Edition of 3D Printing White Paper

Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly:  3D Printing of Manufactured Goods: … Continue Reading

MDR Reporting Final Guidance

FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”.  As with all such guidance documents, it is nonbinding:  “It does not establish any rights for any person and is not binding on FDA or the public.”  Nevertheless, for those interested in medical device reporting, the document is required reading as … 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

FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices

The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug.  It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014.  FDA brought together technical 3D printing expertise from various industries and sectors … Continue Reading

Navigating the Regulatory Issues of 3D Printing

The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Although we have blogged about 3D printing, and the Reed Smith white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” addressed regulatory issues for medical devices and … Continue Reading

Postmarket Cybersecurity Recommendations for Medical Devices Issued by the FDA

We’ve blogged about medical device cybersecurity topics here and most recently here. 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 risks. The draft guidance recommends that manufacturers should execute a structured, systematic, and comprehensive cybersecurity risk management program … Continue Reading

FDA to Hold Upcoming Medical Device Cybersecurity Workshop

The FDA announced that it will be holding a public two-day workshop at its White Oak Campus in Silver Spring, Md., on January 20-21, 2016, from 9:00 a.m. to 5:30 p.m. titled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” The FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department … Continue Reading

Life Sciences Health Industry Group Winter 2015/2016 Course Offerings

The Reed Smith Life Sciences Health Industry Group (LSHI) recently released their “Winter 2015/2016 Webinar Course Offerings,” which once again features timely webinars and in-person programs on a wide variety of topics. Upcoming events include: January 19, 2016 – Webinar: The Good, the Bad and the Ugly: The Best and Worst Prescription Drug/Medical Device January 24, … Continue Reading

IEEE Developing New Standards for 3D Printers For Medical Uses

The Institute of Electrical and Electronics Engineers Standards Association (IEEE) is developing new interoperability standards for medical devices, 3D printers and other eHealth devices.  IEEE P3333.2.5, Draft Standard for Bio-CAD File Format for Medical 3D Printing is intended to develop standard methods for the printing of 3D-printed prosthetics and medical devices.  IEEE proposes to define … Continue Reading

GAO Report Regarding FDA-Ordered Postmarket Studies

Today, the Government Accountability Office (GAO) released a report entitled “Medical Devices: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing.”   According to the report, “GAO was asked to report on the characteristics and status of postmarket studies. This report describes (1) the types of devices for which FDA has ordered … Continue Reading

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

3D printing is quite possibly the next greatest chapter in the industrial revolution, and the technology is moving rapidly.  Reed Smith’s Life Sciences Health Industry Group recently launched its first 3D printing publication white paper – 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles.  This paper explores unchartered legal issues … Continue Reading

Cybersecurity Concerns for Medical Device Companies: A Risk Mitigation Checklist

Cybersecurity issues are nothing new to those operating in the health care industry. But while these issues have most commonly been faced by hospitals and health care providers, medical device companies must now take note. As reported recently in the news, medical devices have increasingly become the targets for cybersecurity breaches, given the information contained … Continue Reading
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