Many Concerns About Emerging Signal Guidance

Industry stakeholders are voicing many concerns about the FDA draft guidance on public notification of emerging postmarket medical device signals. The most comprehensive critique was submitted by the 510(k) Coalition, which “recognizes that FDA is attempting to embark on a major multi-year effort to set up systems to collect massive amounts of real-world, observational data that are more difficult to analyze than data from controlled clinical studies.” The coalition says it found “numerous potentially serious issues in the draft guidance,” including:
         a lack of clear statutory authority to enact the guidance;         a lack of clarity in the draft on whether there is a specific problem that the agency is trying to resolve that it is unable to adequately address under current existing regulations;         a failure to adequately consider the benefit-risk balance to patients since patients and doctors can make erroneous decisions based on agency reports of potential product issues;         a lack of sufficient criteria and evidentiary standards for determining an emerging signal and no statement on the degree of confirmation to be needed before an emerging signal is published;         the potential for FDA to publish information about devices using unreliable sources with uncorroborated data;         a failure of the guidance to discuss procedural steps, both for industry involvement and internal FDA processes;         a failure to describe how final resolution will be reached once the agency determines that something is not actually an adverse emerging signal;         a significant risk that publication of emerging signals by FDA could lead to increased frivolous plaintiff litigation targeting companies for potential device risks that may or may not be valid;         a failure to address whether a company would need to modify its device label due to an emerging signal and a similar failure to discuss what a company is able to do if it disagrees with the agency;

The Medical Device Manufacturers Association (MDMA) says it supports the comprehensive comments from the 510(k) Coalition and adds that the draft “would not achieve the objectives articulated by FDA and, in fact could potentially do more harm than good by providing inaccurate and incorrect data to the public.”

In its comment letter, AdvaMed says the proposed draft “represents a significant departure from the agency’s current postmarket communication practices and may not, by FDA’s own admission, be in the public interest…. We believe this policy and the stated goals of the draft guidance, raise numerous legal, regulatory, and policy concerns.”

AdvaMed cautions that the draft guidance fails to articulate a reasonable basis to communicate emerging signals to the public. It says that the agency acknowledges that release of an emerging signal to the public may deter use of a safe and effective medical device. “A scientifically-driven regulatory agency should define clearly the strength of evidence and uncertainty that has resulted in the public communication of information about previously cleared or approved devices,” the letter says. “Moreover, the release of information that might be, as FDA admits, incorrect, incomplete, or misleading will negatively impact the use of devices and patient well-being.” The letter raises these specific concerns:
         FDA lacks statutory authority to communicate emerging signals;         emerging signals will be confusing and misleading;         device manufacturers must be included in FDA’s process; and         FDA must better define the data and evaluation mechanisms.

Finally, AbbVie says that communication with the sponsor prior to communication of a medical device emerging signal is critical. It notes that the draft does not establish that FDA will notify the sponsor prior to public communication of a medical device emerging signal. It says that prior communication between the agency and the company would harmonize the CDRH process for communicating a medical device emerging signal with CDER’s process for communicating drug safety information. AbbVie also recommends that FDA consider making more timely updates as investigations of emerging signals progress and are completed. The guidance calls for updates at least twice a year or more often as necessary and appropriate. “Confirmation of severity and actions to resolve the associated issue should be as rapid as possible,” the letter says, “as should retraction of the issue if the signal was demonstrated to be inaccurate. Additionally, sponsors will have to receive returned medical devices that may require both servicing and analysis. More timely updates to FDA’s public communications will assist with correctly and accurately reflecting the status of an emerging signal.”