Company's filing influential in FDA shunt reclass:
This article was originally published in Clinica
The US FDA has issued a final guidance document that will allow manufacturers of new endolymphatic shunt tubes with valves to file an abbreviated 510(k) rather than a PMA. The initial guidance document, issued last November in conjunction with a proposed rule reclassifying the product from a high risk, class III, device to a medium risk, class II, device would have required manufacturers to submit a full 510(k) notification. But since then E Benson Hood Laboratories has submitted enough new information on the product that the agency has decided to allow companies to use the less complex abbreviated 510(k) regulatory path in the future.