FDA steps up in regulating safety concerns


Data-Driven Progress

The U.S. Food and Drug Administration (FDA) has established a new objective for itself: “to become the international leader in medical device safety through better use of big data,” according to an article by Conor Hale in FiercePharma. The agency has made a commitment to quick device safety responses “using real-world data and active surveillance,” Hale explained.

The FDA has promised to put first among the world’s regulatory agencies in “identifying and reacting to” device safety concerns by making the transition to an active surveillance system supported by real-world evidence and by establishing new authority to take quicker actions for postmarket safety. Included are plans for modernizing the 510(k) review process and targeted measures involving devices for women’s health, such as surgical mesh for transvaginal repair.

FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren outlined the first new steps of the plan. As they explained in a statement, “We’re evolving beyond our current post-market surveillance system—which is largely passive and relies on device users to report problems to us, sometimes resulting in underreporting. We’re moving to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information. We have long recognized the systemic weaknesses of the passive system—a challenge faced by other countries—and we prioritized this area for regulatory reform efforts.”

The efforts are possible because of the FDA’s unique device identification initiative that tags each device with a code that can be tracked as it is distributed and used in patients. The system’s public database currently has more than 1.5 million records, to help the FDA to “link adverse event reports with specific devices,” the FDA said.

According to Gottlieb and Shuren, “We believe that including the device identifier in electronic data more broadly, including in insurance claims, will advance FDA’s efforts to leverage real-world data to support the development of more effective post-market surveillance tools.” The FDA also is committing new resources to quickly allow its National Evaluation System for health Technology, or NEST, for the analysis of real-world data from patient registries, Medicare claims and electronic medical records. Additionally, NEST will offer information to medical device manufacturers developing improvements for their devices, according to the FDA.

NEST has an independent governing board controlled from a public-private coordinating center, called NESTcc. It includes industry and community stakeholders and patient and provider representatives. The agency provided the seed funding for NESTcc and obtained partial industry funding through the latest version of the FDA’s user fee legislation. NESTcc has made agreements with 12 organizations that represent nearly 200 hospitals and nearly 4,000 outpatient clinics with access to more than 495 million patient records in order to help build out its data network.

The FDA allocated $3 million to NESTcc in September, as well as the annual funding allocated by the latest user fee agreement. The Trump administration has asked for an additional $46 million for fiscal 2019 to support NEST. Recently, NESTcc announced “eight real-world data demonstration projects, exploring the use of patient registry and claim data in evaluating total joint replacement and spine fusion surgeries, as well as the effectiveness of different tissue closure techniques following surgery,” Hale’s article said.

The FDA has slated an advisory committee meeting for February 2019 to discuss surgical mesh intended for transvaginal pelvic organ prolapse repair and to consider additional regulatory actions. Two years ago, the FDA reclassified surgical mesh devices from Class II to Class III, making manufacturers submit them for premarket approval and leaving only three products on the market.

FDA also launched the National Breast Implant Registry in September after public concerns that implants could be linked to health conditions such as chronic fatigue, cognitive issues and muscle pain. The FDA is also continuing to monitor energy-based devices that may be inappropriately marketed for vaginal rejuvenation and symptoms related to menopause, urinary incontinence or sexual function. This past summer, the FDA publicly warned seven manufacturers of its concerns, sparking changes to  websites or removal of unapproved claims.


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