Are Wearables Medical Devices Requiring a CE-Mark in the EU?

Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases allow healthcare professionals to follow-up on the condition or habits of their patients, often in real-time. How do manufacturers determine what wearables qualify as medical devices? How do they assess whether their devices need a CE-mark? Must they differentiate between the actual “wearable” and the hardware or software that accompanies them? In this short contribution, we briefly analyze some of these questions. The article first examines what “wearables” are, and when they qualify as a medical device under current and future EU rules. It then addresses the relevance of the applicability of EU medical devices rules to these products. The application of these rules is often complex and highly fact-specific. Continue Reading

FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics for Oncology Therapeutic Products

On December 6, FDA Commissioner Gottlieb announced in a press release the availability of a new draft guidance entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” (Draft Guidance). The agency also published the Draft Guidance announcement in the December 7 Federal Register. FDA issued the Draft Guidance in an effort to “make it easier to get class labeling on diagnostic tests for oncology therapeutic products, where scientifically appropriate.” The Draft Guidance is part of a broader agency focus on personalized medicine. Continue Reading

CMS Rolls Out Revised Local Coverage Determination Process

On October 3, 2018, the Centers for Medicare & Medicaid Services (CMS) announced a number of changes to the local coverage determination (LCD) process. The new guidelines are outlined in a revamped Chapter 13 – Local Coverage Determinations – of the Medicare Program Integrity Manual (PIM). This manual chapter had been the subject of criticism, with some stakeholders arguing that a lack of transparency potentially denies patient access to innovative treatments. Continue Reading

AI Update: Medical Software and Preemption

In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification Program, is meant to encourage the development of health and medical software, including potentially software using artificial intelligence. Continue Reading

FDA Finalizes Voluntary Malfunction Summary Reporting Program to Streamline Manufacturer Reporting

On August 17, 2018, FDA announced that it finalized its Voluntary Malfunction Summary Reporting Program (“Program”).  The Program is intended to reflect the goals for streamlining manufacturer malfunction reporting that FDA and industry agreed to in the Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter.  The finalized Program is based on positive findings from a 2015 pilot program and public comments submitted to a 2017 Federal Register proposal.

Continue Reading

Medicare Policies Modified to Support Smart Devices Use for Sharing Glucose Data

The Centers for Medicare & Medicaid Services (CMS) recently announced that Medicare coverage policies would be revised “to support the use of [continuous glucose monitors] in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.” In turn, the agency’s contractors, known as Medicare Administrative Contractors (MACs), modified their policies in part to recognize “the use of smart devices (watch, smartphone, tablet, laptop computer, etc.)” (see CMS and MAC announcements here and here). This recent shift is an important precedent for technologies that incorporate the use of electronic devices to display and share medical data, and may foreshadow flexibility in future federal policy development to support the important role smart devices are increasingly playing in communicating medical data. Continue Reading

FDA Issues Two Final Guidances on Communications Not Included In Product Labeling

Last month, FDA issued two final guidances on medical product communications, including communications by medical device companies about unapproved uses of approved/cleared medical products: “Medical Product Communications That Are With the FDA-Required Labeling—Questions and Answers” (CWL Guidance) and “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers” (Payor Guidance). Taken together, these guidances provide considerable additional flexibility for medical device manufacturers to communicate truthful and non-misleading information about their products to health care professionals, payers, and other customers.

Although the final guidances are largely consistent with the draft guidances, issued in early 2017 (available here and here), they provide answers to some questions left open by the draft guidances and new insights into FDA’s thinking on these issues. Continue Reading

Federal Circuit Decision in Medical Device Case Sheds Light on “Exceptionality” Analysis for Attorney Fees

In Stone Basket Innovations, LLC v. Cook Medical LLC, a recent case involving the enforcement of a medical device patent, the Federal Circuit affirmed a district court’s denial of attorney fees under 35 U.S.C. § 285. In its opinion, the court provided helpful guidance regarding the factors that impact a potential award of attorney fees and how a party can position itself for success on a § 285 motion.

In April 2015, Stone Basket Innovations (Stone Basket) filed a patent infringement lawsuit against Cook Medical (Cook), alleging infringement of U.S. Patent No. 6,551,327, a patent directed to a basket-type device used to remove stones from biological systems. In March 2016, Cook filed a petition for inter partes review (IPR) of all claims of the patent. The IPR was instituted as to all claims of the patent and the district litigation was stayed pending the IPR. In December 2016, Stone Basket filed a motion requesting an adverse judgment in the IPR proceeding. The PTAB granted the motion and cancelled all claims of the ‘327 patent. At Stone Basket’s request, the district court litigation was dismissed with prejudice. Following the dismissal, Cook filed a § 285 motion, which was denied because the district court determined that the case was not “exceptional.” The Federal Circuit affirmed. Continue Reading

CMS Announces Enforcement Discretion for New Laboratory Date of Service Exception

This week, the Centers for Medicare & Medicaid Services (CMS) announced (see announcement here) that it is exercising enforcement discretion until January 2, 2019 for its new Medicare laboratory billing rule on the date of service exception. This agency action allows hospitals to continue to bill for affected advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests until the hospitals and those laboratories that would otherwise be responsible for billing under the new rule have developed a billing system that enables the performing laboratory to bill for the tests. CMS made its enforcement discretion decision in response to industry feedback, which suggested that additional time was needed to meet the new rule’s July 2, 2018 implementation date. Continue Reading

CNDA Releases New Rules on the Inspection of Medical Device Clinical Trials for Comment

Last month, the China Nation Drug Administration (CNDA, formerly known as China Food and Drug Administration or CFDA), released a draft rule on Inspection Key Points and Guiding Principles of Medical Device Clinical Trials (“New Draft”). This is the third draft rule related to medical device clinical trial inspections that CNDA has issued in the last two years. The draft rules cover site inspections by CNDA, which began in 2016, of clinical trials for devices that are in the process of product registration. The purpose of the inspections is to evaluate the compliance of these trials with good clinical practices (GCP) and ensure data integrity, which has been a significant concern for CNDA in the drug and device spaces. The drafts refer to the inspections as assessing “authenticity” and “compliance.” Continue Reading