Devices

Safety and Performance Pathway Criteria

FDA has issued two final guidances providing performance criteria for conventional foley catheters and cutaneous electrodes for recording purposes in support of the safety and performance-based pathway. The agency says that under the pathway, medical device manufacturers planning to submit a 510(k) for the devices have the option to use the performance criteria as identified in the final guidances to support substantial equivalence, rather than completing a direct comparison of the performance of the subject device to that of a predicate device.

The guidances are the first issued under the safety and performance-based pathway. The agency says it strongly encourages industry and stakeholders to continue providing FDA with recommendations for additional types of devices that would benefit from inclusion in future guidances regarding performance criteria and testing methodologies for the pathway.

Download the conventional foley catheter guidance here and the cutaneous electrode guidance here.

FDA has scheduled a 9/24 Webinar for industry and others interested in learning more about the guidances.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome