2023-07896: Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters--Premarket Notification (510(k)) Submissions." FDA is issuing this final guidance document to provide recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons).
The agency’s own summary, as published.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →