Respiratory Devices Compliance Best Practices

The U.S. Food and Drug Administration (FDA) requires that manufacturers of medical devices in contact with a patients’ airways or breathing gas pathways validate the biocompatibility of any airway contacting material via their 510(k) Premarket Notification process.

Yet, despite these requirements, the FDA reports that nearly one-third of 510(k) submissions provide inadequate information regarding device biocompatibility or worse, fail to provide any biocompatibility data at all.

The failure to conduct adequate biocompatibility testing or to submit sufficient documentation validating biocompatibility typically results in the rejection of the 510(k) submission or an extended delay in its review by the FDA.

This UL Solutions webinar focuses on:

• The importance of biocompatibility testing of breathing gas pathways in medical devices and how testing in accordance with the technical requirements of the ISO 18562 series of standards can strengthen claims of biocompatibility in support of FDA 510(k) submissions.
• The revised versions of the four standards in the ISO 18652 series that have been published to provide updated guidance based on lessons learned since they were first published in 2017.
• Best practices of a preventive and proactive approach to assessing and testing the biocompatibility for gas pathways in medical devices compliance and the benefits of such approach.