The FDA needed a year to move a draft guidance for emerging medical device safety signals to final form, assuring industry along the way that such disclosures would be handled deftly. At least one trade association raised the question of whether the agency enjoys the statutory authority to issue such advisories in the first place, but as a physician might say, the best medicine for this kind of issue is still prevention.
Statutory authority question gains no traction
The Center for Devices and Radiological Health published the draft “emerging signals” guidance in December 2015 with the acknowledgement that such advisories could lead to a problematic degree of under-utilization. The agency’s argument was that the benefits of such a disclosure would outweigh the risks, perhaps a nod to the benefit-risk draft guidance for regulatory action, which the agency may believe is a necessary companion piece to the emerging signals guidance.
One of the device associations that commented to the docket for the draft guidance argued that the Medical Device amendments do not authorize the disclosure of potential device safety information in the same manner as is found in the provisions governing drug regulation. Another device association asserted that any such announcements by the FDA would be arbitrary and capricious – which by precedent would seem to invite a lawsuit – or at the very least that such a move on the FDA’s part is more appropriately handled via comment and rulemaking rather than by guidance development.
A significant change made for the final guidance is the explicit promise that the FDA would not act on any information it deemed unreliable, unconfirmed, or not backed by sufficient strength of evidence. Industry may find itself flashing back to the drop in utilization of drug-eluting stents seen in 2006 and 2007 after disclosures regarding late-stent thrombosis at a medical society meeting in Barcelona, but the power morcellation question might be seen as a more obvious example of regulatory overreach with or without the help of physician input.
A second difference between the draft and final versions of the emerging signals guidance is that the latter discusses the formation of a group of subject-matter and regulatory experts charged with arriving at some understanding of the meaning of the initial signal. One of the options the agency could exercise is to require that the sponsor conduct additional postmarket studies of the device, while another option would be to suggest the manufacturer make a change to the device label. The exercise of this second option would presumably come up short of a removal of an indication for use, if only because a preliminary signal is not generally accorded sufficient weight to trigger a rescission of a 510(k) or a withdrawal of a PMA or PMA supplement.
More data, more need for compliance
An obvious subtext to the emerging signals guidance is the ongoing stand-up of the National Evaluation System for health Technology, known as NEST, which will take several years and several hundred million dollars to erect. The NEST system would presumably generate large volumes of data about device performance, but such a system might carry the signal-to-noise problem often seen in “big data” concepts. It is impossible for the FDA to guarantee it will not over-interpret a signal, particularly as it will undoubtedly be bombarded with allegations that the 21st Century Cures program will turn the FDA premarket programs into a series of rubber-stamp processes.
Perhaps now more than ever, device makers would do well to toe the line on the recent medical device reporting final guidance, if only to avoid pinging any patella tendons inside and outside the agency. Corrective and preventive action is still a big theme in warning letters, too, and any device maker that is seen as dropping the ball here will curry no favor with the FDA.
There is no guarantee the FDA will not overreact to an “emerging signal,” but companies can do a lot to keep investors and FDAers on their side – and to fend off would-be litigants – by running a tight regulatory ship.