Industry and other stakeholders are taking the FDA to task over draft guidance for communicating new information on safety issues related to medical devices, with one group labeling it a “significant departure” from agency practices.
The comments came in response to draft guidance unveiled Dec. 31, 2015, on so-called emerging signals, which the agency defines as new safety information on a medical device used in clinical practice. The agency wants to communicate these signals at an early stage while it still is monitoring and analyzing the safety information and before it is validated or confirmed.
Specifically, the draft document addresses the criteria, timeframes, communication methods and agency follow-up on communications for emerging signals.
Many stakeholders express concern about the agency’s intention to communicate information about these emerging signals early in the process, as it could cause undue patient alarm. The Medical Imaging & Technology Alliance even goes as far as to urge the FDA to withdraw the draft document.
If the agency moves forward with the document, the group says, it should consider the ramifications of sharing information with the public on an emerging signal that has not been properly evaluated. It highlights a section in which the agency acknowledges that a communication regarding an emerging signal “may lack certainty about the significance of the information.” This lack of certainty could raise public concern needlessly, MITA says.
AdvaMed agrees, saying that the document “fails to articulate a reasonable basis to communicate emerging signals to the public.” The group assails the agency over what it calls a stark departure from existing postmarket communication practices, adding that the propsal “may not, by FDA’s own admission, be in the public interest.”
Further, prematurely releasing emerging signal communications to the public could hurt the reputation of medical devices. Word of unconfirmed risks also could cause “frivolous litigation, class action lawsuits and other legal actions,” AdvaMed says, adding that the agency acknowledges that these communications could be based on “incorrect, incomplete or misleading information.”
The group even questions whether the agency has statutory authority to communicate emerging signals, as it is proposing “sweeping changes” to its postmarket communication policies. Such a proposal is more suitable for rulemaking and public comment, it maintains.
The FDA also doesn’t spell out which of its staff will determine whether a communication is warranted. “Senior staff within FDA should be required to sign off on all early communications to ensure that decisions to issue such communications are consistent and scientifically appropriate,” AdvaMed contends.
The 510(k) Coalition raises the question of what happens if the FDA determines no safety issue is posed by a device after issuing this communication.
In the draft guidance, the FDA says it will post updates on its website at least twice a year — or as often as it deems appropriate. It will do so until it can issue a formal safety communication with specific recommendations for affected parties.
However, the coalition doesn’t believe the agency has provided enough clarification. “It is unclear, how, or whether, FDA would be able to adequately publicly announce that an Emerging Signal was a false one and to also undo any damage … to ensure that the product and/or company’s reputation isn’t forever tarnished,” the group writes.
AdvaMed also takes aim on this aspect of the proposal, saying updates should be more frequent, and the agency should immediately notify the public if no causal relationship can be demonstrated between a safety issue and a device.
A MedWatch Approach
Not all commenters are so hard on the FDA’s proposal. The American Society of Anesthesiologists says it is supportive of the general concept of emerging signals, but adds that some clarification is needed on how the process would work.
To that end, it recommends that communications be administered through a system akin to the agency’s MedWatch alerts. The group also suggests identifying emerging signals by specialty and allowing organizations to subscribe to appropriate alerts.