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Zdrowie i gospodarka · 07/12/2001

Medical Devices: Draft Guidance on Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Cardiac Ablation Catheters Generic Arrhythmia Indications for Use." This draft guidance document encourages manufacturers of approved conventional cardiac ablation catheters to submit supplements to broaden their labeling from arrhythmia-specific indications to a generic arrhythmic treatment indication. The Center for Devices and Radiological Health (CDRH) is issuing this draft guidance document to allow companies to label these products for a broader indication without submitting additional clinical information. This recommendation is based on a comprehensive search of the medical literature. This draft guidance is neither final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →