Tag Archives: medical device

EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?

Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here).  This presents a good opportunity to have a closer look at one of the essential questions … Continue Reading

House Discussion Draft Released on Regulatory Approach for In Vitro Clinical Tests

On March 20, 2017, Rep. Larry Bucshon (R-IN) and Rep. Diana DeGette (D-CO) released a discussion draft of the Diagnostic Accuracy and Innovation Act (DAIA).  DAIA would regulate “in vitro clinical tests,” defined in the discussion draft as a “laboratory test protocol or finished product” intended for clinical use “in the collection, preparation, analysis, or … Continue Reading

FDA Releases Draft Guidance on Manufacturers’ Communications with Payors

In January, FDA released a Draft Guidance on Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities (“Draft Guidance,” available here), which provides the Agency’s thinking on communications with payors in two areas: (1) communication of health care economic information to payors regarding approved drugs; and (2) communications to payors about investigational … Continue Reading

2016 Year in Review: FDA Advertising & Promotion Enforcement Activity

Warning and untitled letters issued to manufacturers of medical products offer unique insight into FDA’s enforcement practices. To help identify themes and trends in the agency’s recent enforcement activity, Covington & Burling has reviewed all warning and untitled letters related to advertising and promotional materials issued in 2016 and tabulated the most frequently cited allegations. … Continue Reading

EU Medical Devices Regulation Series: Interpreting the “Industrial Scale” Concept

The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation. To provide perspective on the meaning of “industrial scale” and how the draft MD Regulation’s use of the term may be … Continue Reading

CFDA Releases Draft Classification Catalogue of Medical Devices

The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of the … Continue Reading

EU Medical Devices Regulation Series on Key Issues

It has been fairly quiet since the political agreement was reached last June on the EU Medical Devices Regulation (“the Regulation”). While the Commission’s lawyer-linguists iron out the final language, paving the way for formal adoption in the coming months, we are preparing a series of articles, beginning with this blog post, to address key … Continue Reading

eHealth and mHealth Software Classification Changes in Forthcoming EU Medical Device Regulation

The new EU Medical Devices Regulation (MDR), a draft of which was tentatively agreed by the EU’s legislators on June 15, 2016, was revised at the last minute to include a new classification rule for software. Software’s classification under the MDR will determine its regulatory treatment (including what requirements it has to meet, and what … Continue Reading

CMDE Releases New Inquiry Rules on Medical Device Technical Review

On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE) released Guidance for the Management of Inquiry on Medical Device Technical Review (“New Guidance”).  The New Guidance replaces CMDE’s Guidance for the Management of Technical Inquiry on Registration of Medical Device (effective as of March 26, 2007, the “Prior … Continue Reading

CFDA Releases New Administrative Measures on Medical Device Recalls for Comment

The China Food and Drug Administration (CFDA) is expanding its reach over device recalls. In early September, CFDA released a long-awaited draft of the Administrative Measures on Medical Device Recalls (Proposed Rules).  These significantly-expanded measures would replace the current medical device recall rules that the Ministry of Health (now the National  Health and Family Planning … Continue Reading

Is Medical Software a Medical Device? European Court of Justice to Decide

On June 13, 2016, the French Conseil d’État (supreme administrative court) referred to the EU Court of Justice (“CJEU”), the question of whether medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device under Directive 93/42 (the “Directive”) (Case C-329/16).  The qualification of software as a medical … Continue Reading

FDA Finalizes General Wellness Guidance

Last week FDA finalized a guidance document entitled “General Wellness: Policy for Low Risk Devices” in which the agency sets forth an approach to not regulate “general wellness products.”  This guidance document is important to the rapidly growing market for wellness products, which includes such things as activity trackers, smart watches, mobile apps, and other … Continue Reading

District Court Opinion Provides Guidance for Extensions of Medical Device Patents Containing Method Claims

Last month, the Eastern District of Virginia held that a patent covering a medical device may not be eligible for an extension unless the patent “claim[s] the use of the particular product that underwent FDA review.”  The case serves as an important reminder that, for purposes of securing a patent term extension, applicants claiming methods … Continue Reading

Impact of Brexit on EU Medical Devices Regulation and Structures

The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU … Continue Reading

CFDA Releases New Self-Assessment Reporting Requirements for Medical Device Distributors

On June 7, 2016, the China Food and Drug Administration (“CFDA”) released the Notice on Regulating Distribution Activities in Medical Device Circulation (“Notice”). The Notice requires that distributors of Class II and III devices assess their compliance with Medical Device Good Supply Practices (“GSPs”) and other medical device regulations over the course of the last … Continue Reading

FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations

On May 17, 2016, FDA issued draft guidance encouraging clinical investigators to make their electronic data capture (“EDC”) systems interoperable with health care organizations’ electronic health records (“EHRs”).  Although EHRs are generally under the control of health care organizations and institutions (not FDA-regulated entities such as sponsors), when records are used in clinical investigations, FDA … Continue Reading

China’s New Medical Device Good Clinical Practices to Go Into Effect June 1, 2016

The China Food and Drug Administration (“CFDA”) and National Health and Family Planning Commission of China (“NHFPC”) have jointly released a revised and substantially expanded set of Good Clinical Practices for Medical Device Clinical Trials (“New Device GCP”), which will go into effect on June 1, 2016.  The New Device GCP are an important piece … Continue Reading

CDRH Schedules January 2016 Cybersecurity Workshop

CDRH has scheduled a cybersecurity workshop entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” on January 20-21, 2016 (see here for the Federal Register announcement). Background and Workshop Context As we discussed in a previous blog post, cybersecurity vulnerability is an increasing concern as medical devices are becoming more connected to the Internet, hospital … Continue Reading

CFDA Restructures Medical Device Adverse Event Regulations

Following a significant revision of its framework medical device regulation (see our alert, here), the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission (“NHFPC”) have released a proposed revision to the Administrative Measures on Monitoring Medical Device Adverse Events and Re-Evaluation (“proposed Measures”), which is the primary regulation for … Continue Reading

CDRH Schedules Next Generation Sequencing Workshops

CDRH has scheduled two next generation sequencing (NGS) workshops on November 12 and 13, 2015 (see here and here for the Federal Register announcements) to further advance the conversation with stakeholders on the Agency’s development of new regulatory strategies for NGS-based clinical tests.  These workshops will build upon a discussion paper published in December 2014, … Continue Reading

FDA Issues Draft Guidance on Determining when Data from Foreign Clinical Studies Can Support Device Submissions

It is becoming increasingly common for medical device companies to conduct clinical studies outside the United States and then seek to use data from these foreign studies in regulatory submissions to FDA. In a draft guidance issued on April 22, 2015, FDA lays out the factors it considers when confronted with data from foreign studies … Continue Reading

FDA Issues Draft Guidance Concerning the Use of Electronic Informed Consent in Clinical Investigations

On March 9, FDA announced the availability of a draft guidance document focusing on the use of electronic informed consent (eIC) in clinical investigations. The document provides recommendations for investigators, sponsors, and institutional review boards (IRBs) concerning eIC, which refers to “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, … Continue Reading
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