Medical Device Legal News with Sam Bernstein: Episode 18
Sequels are rarely better than the films that precede them, and yet, sometimes a story is just too compelling to be limited to just one film. At the tail end of a summer full of Hollywood sequels, the Department of Defense...more
This episode, Sam is joined by Sophie Mouros to discuss: a clinical trial fraud case involving allegedly fabricated data, the FDA’s withdrawal from the medical device Global Harmonization Working Party, the FDA’s recent...more
With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that it will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer...more
On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a requirement that manufacturers of...more
Channeling Johnny Nash and the 1972 classic song, “I Can See Clearly Now,” on July 7, 2021, the Food and Drug Administration issued its final guidance titled, “Unique Device Identification System: Form and Content of the...more
As of this week, Apple’s requirements for apps to follow its AppTrackingTransparency are now in effect. These requirements went hand-in-hand with the iOS 14.5 launch, and impacts how an app can track users and access their...more
In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the...more
The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated...more
On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED. Legacy devices are...more
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this...more
The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and...more
A recent Marketplace Tech podcast episode on the spike in demand for mental health apps caught our attention. As shocking headlines and stay-at-home orders rolled across the country, demand for mental health apps increased...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. The Open Payments reporting requirements,...more
Have you ever looked at a product online and realized it was following you around the internet? Have you ever visited a different website and seen the item you were just thinking about purchasing? These friendly reminders are...more
The Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...more
The California Consumer Privacy Act ("CCPA") was enacted in early 2018 as a political compromise to stave off a poorly drafted, and plaintiff’s friendly ballot initiative. Although the CCPA is scheduled to go into force in...more
Companies should act now to prepare for the full implementation of the MDR and IVDR. On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more
I. Introduction. Using method claims to protect a device is often overlooked because conventional thinking equates device protection with only device claims. A device can, however, be protected by method claims, because a...more
Listed as part of the semi-annual Unified Agenda of Federal Regulatory and Deregulatory Actions, a new proposed rule will require drones registered with the Federal Aviation Administration (FAA) to display a unique identifier...more
The Financial Stability Board has opened a second consultation on governance of the Unique Product Identifier. The FSB identified UPIs in September 2014 as a critical element towards a mechanism to produce and share global...more
On November 29, 2017, the U.S. Court of Appeals for the Ninth Circuit joined the Third Circuit in narrowly defining “personally identifiable information” under the Video Privacy Protection Act (VPPA), holding in Eichenberger...more
The Ninth Circuit recently became the third federal appellate court to tackle what constitutes “personally identifiable information” protected by the Video Privacy Protection Act of 1988 (“VPPA”). Last year, the First Circuit...more
In a decision that clarified aspects of the video privacy landscape, the Ninth Circuit affirmed the dismissal of an action alleging a violation of the Video Privacy Protection Act (VPPA) based on an assertion that ESPN’s...more
On October 16, 2017, the Federal Circuit affirmed the district court’s ruling that the claims in Secured Mail Solutions LLC, v. Universal Wilde, Inc. (“Secured Mail”) were directed to patent-ineligible subject matter under 35...more