Who Owns the 510(k)?
Maria E. Donawa
Donawa Consulting
Recently, a medical device manufacturer located outside the United States (US) mistakenly believed that only someone in the US was able to submit a premarket notification, otherwise known as a 510(k), on his behalf. As a result, the manufacturer agreed to have a US distributor submit the 510(k) to the US Food and Drug Administration (FDA). It was only after the submission was filed that the manufacturer realised that he could have submitted the 510(k) directly to FDA or requested that the US distributor specify that the manufacturer was the applicant and owner of the 510(k). This mistaken belief led to significant financial consequences for the manufacturer because of agreements that had to be made with the distributor who owned the 510(k).
Unfortunately, some companies, both in and outside the US, continue to believe that only entities residing in the US can file a 510(k). This can lead to nonUS medical device manufacturers unnecessarily ceding the ownership of a 510(k) to the party that submits the 510(k) to FDA.
LED Multiplexer Brightens Up Medical Device Market
The lights of bulky, heat-generating, bulb-based illumination sources are dimming compared with compact light-emitting diode (LED) systems that can last 10 to 20 times longer. Recognizing that few LED multiplexing modules were available to OEMs, Bookham Inc. saw the light at the end of the optical filter tunnel. Rather than using lenses to capture light in free space, it has designed its LED module to trap light in a tunnel of highly reflective dielectric-coated surfaces that are geometrically optimized for efficient light collection and filter performance.
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