FDA lays out plans to improve post-market medical device oversight

The FDA today laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology.

In an official posting, FDA head Dr. Scott Gottliebb and FDA Center for Devices and Radiological Health head Dr. Jeff Shuren laid out plans that they, and the agency, hope will address safety concerns that emerge after new devices hit the market and that will improve general overall safety in medical devices.

To begin, the FDA said that it set an “ambitious new goal” in device safety: Ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

The federal watchdog said that to attain this goal it will move beyond its existing post-market surveillance system, which it said is “largely passive and relies on device users to report problems to us,” into a new active surveillance system.

The new system, which will operate around the FDA’s unique device identification system, will rely on real-world evidence and the “timely receipt” of safety information in an attempt to eliminate weaknesses inherent with the passive system, the FDA wrote.

The agency said that as part of the development of a better post-market system, it is investing more resources in developing its National Evaluation System for health Technology, or NEST.

“We’re now committing new resources to NEST to advance a more rapid build-out of this system,” FDA heads wrote in their posting. “In some cases, we already are receiving clinical evidence more quickly and more efficiently and are answering post-market questions we would not have been able to easily address in the past. NEST also will provide another source of information for medical device manufacturers to assess the safety and effectiveness of their devices and continue to develop innovative improvements. Importantly, it will help health care providers and patients stay better informed about the evolving benefit-risk profile of devices on the market and enable them to make more informed decisions.”

The FDA said that to succeed in being the first in the world in terms of device safety will “rest in part on our ability to fully leverage NEST as an active surveillance and evaluation system.”

The agency added that it has already “made strides” towards this endgame, having provided seed funding for the NEST coordinating center, or NESTcc, which now has agreements with 12 organizations representing more than 195 hospitals and nearly 4,000 outpatient clinics with access to 495 million patient records.

Despite the strides, NEST will require “considerably more funding to fully meet its tremendous potential,” the group said, adding that it invested $3 million into NESTcc in September.

To meet those needs fully, the agency said that the President’s budget for the fiscal year 2019 includes a request for an additional $46 million for CDRH to support NEST, as well as for post-market studies to address device-specific safety concerns.

“If this funding becomes a reality, the FDA will continue to work with stakeholders to help make NEST financially self-sustaining in the long term,” the FDA wrote.

The federal watchdog said that it will also continue to develop its Coordinated Registry Networks, with a focus on devices designed to treat women’s health issues. The FDA said that it is partnering with the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, the National Library of Medicine on what it calls the Women’s Health Technologies CRN, or WHT-CRN, having targeted part of the additional $3 million in funding for NESTcc specifically for the product.

So far, the project has developed core data sets in four clinical areas – stress urinary incontinence, pelvic floor disorders, uterine fibroids and long-acting reversible contraception and sterilization therapies, the FDA said.

The next step in the project includes an implementation guide for participating registries to better extract clinical data, and assessing the feasibility of using EHRs to study meshes, the FDA wrote. It also announced the launch of an advisory committee meeting on February 12 looking to discuss the safety and efficacy of surgical meshes for treating transvaginal pelvic organ prolapse.

A separate project, launched in September, will look to evaluate real-world data on the safety and performance of breast implants, the agency said.

The agency added that it plans to unveil new actions intended to “fundamentally modernize” medical device review, particularly the 510(k) process, next week.

“Ensuring the safety of medical devices on an ongoing basis requires a multi-layered effort. One element of this system is a vigilant post-market surveillance system for quick identification and evaluation of new or increased safety concerns. Robust oversight of safety also requires, timely public communication about safety issues and effective interventions to address concerns. The FDA also must foster innovation that spurs the development of safer, more effective technologies and assures timely patient access,” FDA heads wrote in the posting. “Doing all of these things, and more, will enable us to improve the safety, health and quality of life of patients and enable decision-making based on the best available evidence about medical devices.”

Medtech industry group AdvaMed lauded the move from the FDA, with head Scott Whitaker calling the plan a “positive step.”

“Patient safety is the number one priority of the medical technology industry, and we are always willing to look at new ways of ensuring patient safety — whether on the regulatory end with FDA, or on the manufacturing and distribution side with new tools for monitoring and preventing adverse events. This is a collective effort, and one we can continually improve when we work together. FDA’s latest updates to its Medical Device Safety Action Plan are another positive step in this collective effort, and we’re ready to work with the agency and other stakeholders on ways to support the continued safety and effectiveness of medical devices,” Whitaker wrote in an AdvaMed release posted today. “While we’re still reviewing the details of FDA’s updated Safety Plan, industry has long supported many of the programs highlighted, including development of the  National Evaluation System for health Technology to more efficiently generate better evidence on device performance and deployment of a unique device identification system to ensure companies can effectively identify their products through their distribution and use while ensuring patient access to the most innovative, life-saving technologies.”

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