FDA issues guidance on PTA balloon and specialty catheter 510(k) submissions

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The US Food and Drug Administration (FDA) has released draft guidance detailing the information device-makers should include in 510(k) submissions of catheter-based devices intended to treat peripheral vasculature lesions.

The guidelines, which cover class II peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters—including infusion catheters, PTA balloon catheters for in-stent restenosis and scoring/cutting balloons—include suggestions on labelling, performance testing, biocompatibility, and other issues.

Labelling should include information on indications, contraindications, warnings, product information, directions for use and a summary of clinical trial data, if applicable, the agency said.


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