January 18, 2018

FDA Seeks to Strengthen Public Warnings and Recall Notifications; CDRH Outlines Strategic Priorities

January 18, 2018—US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, issued a statement on the agency's new policy steps for strengthening public warnings and notifications of recalls. Additionally, Dr. Gottlieb issued a statement on January 16 in response to the US Government Accountability Office report regarding the FDA’s ongoing commitment to employing a least burdensome approach to device review.

In the statement on recalls, Dr. Gottlieb announced the publication of a draft guidance that describes the FDA’s policy on public warning and notification of recalled products as part of the agency's effort to ensure better, more timely information reaches consumers.

This guidance, which covers drugs and medical devices, as well as food and cosmetics, outlines circumstances when a company should issue a public warning about a recall and describes the general timeline for companies to issue such a warning. Additionally, it discusses what information should be included in a public warning and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient.

The draft guidance also describes the agency's policy for moving forward with posting recalls to the FDA’s Enforcement Report—a listing of all recalls monitored by the FDA—before a final health risk determination is made.

The draft guidance gives industry clear direction on how to navigate and work with the FDA to ensure that recalls are communicated promptly and it will empower consumers by providing more timely and more accurate information on recalled products.

In the statement, Dr. Gottlieb commented, "Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe products, are high priorities of mine. Our recall authorities—and how we deploy them—are a cornerstone of our vital consumer protection mission and I take these obligations very seriously."

He continued, "The draft guidance issued today is just the first in a series of policy steps we’ll take this year as part of a broader action plan to further improve our oversight of food safety and how we help implement the recall process. We all know that hazardous recalled products can have a devastating impact on human lives. We’re committed to making sure that recalls are initiated, overseen, and completed promptly and effectively to best protect consumers and we will use all the tools at our disposal to carry through on this commitment."

In the second statement on least burdensome approach to device review, Dr. Gottlieb noted that the FDA recently issued a draft guidance on The Least Burdensome Provisions: Concept and Principles that clarifies the guiding principles for how the FDA intends to implement and go beyond additional “least burdensome” provisions enacted by Congress in the 21st Century Cures Act, including assessing the minimal amount of information necessary for assuring the safety and effectiveness of new devices. This will allow innovations that benefit patients to reach them more efficiently by collecting the right kind of data at the right time, while maintaining our standards for device review and approval.

In a related development, the FDA's Center for Devices and Radiological Health (CDRH) has released its 2018–2020 Strategic Priorities. The priorities focus on a more systematic application of these concepts: Employee Engagement, Opportunity, and Success; Simplicity; and Collaborative Communities.

As summarized in the document, the first element recognizes the connection between taking care of CDRH's employees and achieving the agency's vision. The document notes that engaged CDRH employees are the most productive, creative, loyal, motivated, and committed to the mission and vision and are less likely to leave. However, engagement requires work life balance, open dialogue, and opportunities to succeed. The second, Simplicity, is about how CDRH addresses the challenges of achieving the mission and vision in the issues presented to the agency. Finally, the Collaborative Communities concept acknowledges that CDRH serves the American public better and achieves its vision when stakeholders in the medical device ecosystem, including CDRH, proactively work together to solve both shared problems and problems unique to others.

Among the strategic priorities emphasized byCDRH is the goal of having more than 50% of manufacturers of novel technologies for the US market intend to bring those devices to market domestically first, or in parallel with other markets, by December 31, 2020.


January 22, 2018

Surmodics' Telemark Support Microcatheter Receives FDA Clearance

January 18, 2018

SAVE-US Pivotal Trial Begins for Bluegrass Vascular's Surfacer Inside-Out Device