Our recent e-Alert provides a detailed analysis of the proposed framework described in the two documents FDA provided to Congress. The drafts describe a risk-based and phased-in approach to applying the medical device requirements of the FDCA to LDTs. FDA’s drafts also describe continued enforcement discretion for certain regulatory requirements and types of LDTs. The documents outline in general terms proposed timelines for phased-in compliance.
On July 31, 2014, the Food and Drug Administration (FDA) released a final guidance entitled “In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff” (the Final Guidance). The Final Guidance explains FDA’s views on development, review, and authorization of in vitro diagnostic (IVD) devices that provide essential information for the safe and effective use of a therapeutic product—called IVD companion diagnostic devices—and is relevant to sponsors of both therapeutic products and diagnostic devices.
On July 31, 2014, President Barack Obama issued a new executive order requiring federal government contractors to disclose labor violations when competing for contracts valued at more than $500,000. The new executive order also requires contractors to periodically report labor violations throughout contract performance, provide employees with accurate information explaining the basis for their pay, and, in more limited circumstances involving the acquisition of non-commercial items, the option to refuse to arbitrate claims of discrimination, sexual assault, or sexual discrimination. Although the new reporting requirements apply to all government contractors, information provided by medical device manufacturers and suppliers may be subject to heightened scrutiny. Two reports referenced in a fact sheet accompanying the new executive order specifically identify members of the medical device industry in highlighting that government contracts have been awarded to companies with multiple labor law violations—a circumstance that the new executive order is designed to prevent.
On 18 July 2014, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it will create a new independent Devices Expert Advisory Committee (DEAC) before April 2015.
The DEAC will be responsible for providing independent expert advice to help the MHRA regulate medical devices. The MHRA hopes that the DEAC will help the MHRA “have stronger links with the wider scientific community to facilitate access to specialist expertise.” The DEAC is expected to be relatively small in size with around 12 members and a chair to enable the group to be more agile and responsive to important regulatory issues concerning medical devices.
In a major announcement, on July 31, FDA notified Congress of its intent to issue two draft guidance documents that, if finalized, would implement a new regulatory system for laboratory developed tests (LDTs). These guidance documents have been anticipated for several years, with the agency announcing over four years ago that it intended to change its regulatory policies for LDTs. FDA’s draft guidance documents include the following:
- “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).”
- “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).”
The European Commission’s Borderline and Classification Medical Devices Expert Group has published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software. The manual also provides new guidance on the classification of two distinct borderline medical device-medicinal products, namely, a riboflavin solution for the treatment of keratoconus and dentistry products with aluminium chloride used in haemostasis.
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 summary.” This guidance is a companion to FDA’s 2013 guidance on CDRH Appeals Processes, which describes the processes for seeking an appeal within CDRH as well as the statutory timeframes for the processing of appeals of significant decisions (for our earlier discussion on this guidance, see here).
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 Biologics Evaluation and Research (CBER) as well as the Center for Devices and Radiological Health (CDRH). Although FDA notes that this guidance is “not intended to implement significant policy changes,” the guidance clarifies and addresses many key issues in the 510(k) program. FDA describes in detail the Agency’s critical decision points in the 510(k) review process and updates the 510(k) review flowchart that was first introduced in 1986. This guidance also discusses key concepts in the 510(k) program, such as the difference between “indications for use” and “intended use,” the use of multiple predicates, and requests for clinical data.
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, in August 2011, Public Citizen filed a citizen petition asserting that POP devices “offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh” and “have high rates of serious complications.” Public Citizen requested that the agency take the following actions: (1) ban the marketing of all available non-absorbable surgical mesh products for transvaginal repair of POP; (2) order all manufacturers to recall these products; and (3) classify all new non-absorbable surgical mesh products for transvaginal repair of POP as class III devices and approve the products only under a premarket approval application (PMA).
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 its recently completely revised Medical Device Supervision and Administration Regulation (MDR), which became effective on June 1, 2014.