FDA reopens comments on decade-old stent guidance

Dive Brief:

The FDA is seeking comments on two decade-old documents about the development of coronary drug-eluting stents.
The documents form part of a backlog of draft medical device guidance documents that were released for consultation but never finalized.
FDA officials will use the feedback to revise the documents and thereby further their efforts to clear up the stack of draft guidances the agency issued prior to October 2012.

Dive Insight:

The FDA first sought feedback on its approach to the nonclinical and clinical development of coronary drug-eluting stents in 2008. Back then, the FDA shared a draft guidance document and a second companion text. Trade group AdvaMed and a handful of other organizations offered broadly-positive feedback on the texts but the FDA never finalized them in light of the feedback.

Now, the FDA is again asking organizations to comment on the drafts, which are identical to those released for consultation in 2008. By reopening the comment periods, the FDA hopes to gather new information that will help it create revised versions that will then undergo further consultation.

In doing so, the FDA’s Center for Devices and Radiological Health will move a step closer to meeting its commitment to finalize, withdraw or reopen the comment period for half the existing draft guidances it issued prior to October 1, 2012. The commitment is part of an ongoing effort by the FDA. In 2015, the agency made the same commitment about drafts released before 2009.

The re-opening of the comment period comes days after physicians writing in The Lancet used data from a head-to-head comparison of Medtronic’s Resolute Onyx and Biotronik’s ultra-thin-strut stent Orsiro to highlight the limitations of noninferiority clinical trial designs.

“Noninferiority trials with combined clinical endpoints in allcomer populations were suggested as a compromise between premarket assessments and speed of innovation. However, it is important to remain aware of the limitations of the information provided by these trials,” the physicians wrote. “Noninferiority trials are sensitive to many methodological issues that potentially affect the final results, and are not powered to provide definitive information about safety."