In Case You Missed It: Top 10 "Gray Sheet" Stories In October
This article was originally published in The Gray Sheet
Our most popular stories last month focused on how device firms respond to FDA inspection reports; guidelines from the agency on how to handle manufacturing site changes; product labeling matters; and off-label marketing rules, among other topics.
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The agency is taking another stab at clarifying its views on when a 510(k) is needed for a device modification in a draft guidance it hopes to issue next year, after having to abandon its 2011 effort in the face of stakeholder revolt. The device center's Michael Ryan previews what to expect.
Competing visions of the future of percutaneous coronary interventions were on display at TCT year, with Boston Scientific pushing its Synergy bioabsorbable polymer-coated, drug-eluting metal stent platform as the better long-term option to fully-resorbable scaffolds of the type Abbott is first out of the gate with.
As industry continues to nudge CMS to follow FDA's lead in making reforms that streamline the path to market for innovative new devices, the agencies are themselves floating solutions. All sides are thinking up strategies to rely on FDA's determination that a device meets certain "breakthrough" standards to trigger a streamlined path to data-conditioned reimbursement. But some in industry are concerned about an overemphasis on national, rather than local, coverage, and, in particular, the Medicare coverage-with-evidence-development process.