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Satisfying CDRH and FDA's 510(k) Demands for Device Reliability with a Complex Electromechanical Device: eFlow(R)

Seemann S, Weinstein L.

Respiratory Drug Delivery 2006. Volume 1, 2006: 279-286.

Abstract:

In order to market a medical device for human use in the United States, manufacturers must go through one of two evaluation processes: premarket notification [510(k)], unless exempt, or premarket approval (PMA). In general, nebulizers are considered class II products and cleared for commercial distribution in the U.S. by the premarket notification [510(k)] process. The eFlow is an electronic nebulizer using a novel liquid aerosol generation principle. In December 2003 the eFlow 510(k) premarket notification was submitted to FDA and in May 2004 the marketing clearance was received. The example of eFlow shows that no matter how well prepared a 510(k) application might be, one has to be prepared for questions on any area where FDA experience may challenge the assumptions from the manufacturer.