Tag Archives: medical device

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FDA Issues Draft Guidance on Determining when Data from Foreign Clinical Studies Can Support Device Submissions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 In a draft guidance issued on April 22, 2015, FDA lays out the factors it considers when confronted with data from foreign studies … Continue Reading

FDA Issues Draft Guidance Concerning the Use of Electronic Informed Consent in Clinical Investigations

On March 9, FDA announced the availability of a draft guidance document focusing on the use of electronic informed consent (eIC) in clinical investigations.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

FDA Proposal to Regulate LDTs Raises Legal Liability Questions for Labs

Back in August, we wrote about the FDA’s controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) —  diagnostic tests developed by and used within individual laboratories across the country.  As it stands now, LDTs are overseen by the Centers for Medicare and Medicaid Services under the Clinical … Continue Reading

21st Century Cures Discussion Draft Act Proposes Changes to Medical Device Regulation

A discussion draft of the highly anticipated legislation, the 21st Century Cures Act, was released on January 27, 2015 (Draft Act). The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce (E&C) Committee. The Draft Act contains five titles that are … Continue Reading

CFDA Proposes New Regulations on the Accreditation of Medical Device Trial Sites

On December 15, 2014, the China Food and Drug Administration released proposed Measures for the Accreditation of Medical Device Clinical Trial Institutions (Measures) for public comment. The comments are due on February 28, 2015. The Measures articulate the process by which medical institutions in China can apply to the government to become accredited to conduct … Continue Reading

FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories

FDA published two much anticipated draft guidances on January 16, 2015, which outline the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although not solely focused on software, these guidances provide further clarification to the rapidly developing and expanding mobile app and software … Continue Reading

Latest Proposal to Repeal Medical Device Excise Tax Gains Traction

On January 6, Representative Erik Paulsen (R-MN) introduced the latest bill to repeal the 2.3% excise tax on medical devices imposed by the Affordable Care Act, commonly referred to as “ObamaCare.”  Legislators have introduced similar legislation each year since the tax was passed in 2010.  The current bill (H.R. 160) has over 250 cosponsors, including … Continue Reading

FDA Focuses on Sex-Specific Data in Medical Device Clinical Trials

On August 22, 2014, FDA issued a final guidance addressing the collection and analysis of sex-specific data in medical device clinical trials, entitled “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.”  The guidance outlines “FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information.”  According to the guidance, studying both sexes … Continue Reading

Decision Requiring Commercial-Item Suppliers to Comply with Non-Standard Terms under the FAR Is Stayed Pending Appeal

Medical device manufacturers and life sciences companies frequently supply commercial products and services to the U.S. Government under the Federal Supply Schedule (FSS) or General Services Administration (GSA) Schedules program.  For example, in one such program managed by the Department of Veterans Affairs, suppliers provide surgical instruments, hospital equipment, and surgical dressing materials to the … Continue Reading

China Issues Multiple Final Rules and Proposals to Implement Recent Revisions to its Core Medical Device Regulation

Throughout August 2014, the China Food and Drug Administration (CFDA or the Agency) made significant process in issuing finalized rules and guidances to implement the revisions to its core medical device regulation, the Medical Device Supervision and Administration Regulation (MDR) (see our alert, here).  The State Council revised the MDR in March, and it went … Continue Reading

FDA Finalizes Appeals Guidance on Section 517A

On July 30, 2014, FDA issued a final guidance, “Center for Devices and Radiological Health Appeals Processes:  Questions and Answers About 517A,” which provides an interpretation of key terms for appeals of certain CDRH decisions under section 517A of the Food, Drug, and Cosmetic Act (FDCA), including what constitutes a “significant decision” and a “substantive … Continue Reading

FDA Finalizes Guidance on the Evaluation of 510(k) Substantial Equivalence

On July 28, 2014, FDA issued an important final guidance relating to the Agency’s substantive review of 510(k) notifications, entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”  This guidance applies to the 510(k) review process for both diagnostic and therapeutic devices and is applicable to 510(k) reviews undertaken by the Center for … Continue Reading

FDA Denies Citizen Petition’s Request to Ban Marketing of Non-Absorbable Surgical Mesh Products for Transvaginal Repair of Pelvic Organ Prolapse

On July 14, 2014, FDA publicly posted its response denying Public Citizen’s August 2011 citizen petition concerning the marketing of non-absorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP).  In its response, FDA took the position that a ban or recall of POP devices is not warranted at this time. As background, … Continue Reading

China Releases New Notification Procedures for Class I Medical Devices

The China Food and Drug Administration (CFDA) issued a Notice on Items Related to Class I Medical Device Notifications (Notice) to establish new notification procedures for Class I medical devices, which includes in vitro diagnostics.  This Notice is one of several that CFDA issued at the end of May 2014 related to the implementation of … Continue Reading

CFDA Clarifies Implementation Issues for New Medical Device Regulation

On June 1, 2014, the newly revised Medical Device Supervision and Administration Regulations (revised MDR) took effect.  The revised MDR has changed medical device regulation in China significantly (described here), but some of the revised provisions conflict with implementing rules for the prior MDR that are still legally effective.  Although the China Food and Drug … Continue Reading

FDA Launches OpenFDA To Ease Access to FDA Datasets — Which Creates Opportunities for Developers of Mobile Medical Apps

Last week, FDA launched openFDA­—its new, open government initiative.  Created in response to an executive order on transparency, openFDA will provide access to many of the agency’s health data sets.  FDA is encouraging developers of websites and mobile medical apps to process FDA’s health data so it is more useful for the public, clinicians, and … Continue Reading

FDA Issues Draft Guidance on Voluntary Consensus Standards

On May 13, 2014, FDA announced the availability of a draft guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”  When finalized, the guidance will supersede FDA’s September 2007 guidance on the use of consensus standards.  The draft guidance is intended to provide further clarity to industry and FDA staff … Continue Reading

China Issues Special Procedures for Innovative Medical Devices

In February 2014, the China Food and Drug Administration released Trial Procedures for the Special Examination of Innovative Medical Devices (Special Procedures).  CFDA released a draft of the Special Procedures for public comment in mid-2013, described here.  Under these special procedures, if a medical device meets certain criteria it will be eligible for “priority” evaluation … Continue Reading

International Consensus on “Software as Medical Device” Definition

Last December, the International Medical Device Regulators Forum (IMDRF) reached a consensus on a potentially key aspect of the future regulation of medical software in the US, the EU, Brazil, Canada, and Japan, that is, a harmonized definition of when stand-alone software will be considered to be a medical device. This category of software, dubbed … Continue Reading
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