MDDI_Medical Device & Diagnostic Industry

MDDI, June 2014

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MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY JUNE 2014 | 25 broader indications from the onset, you might have met resistance. Are these approaches just operating within the rules, or are they cheating? Or if not outright cheating, is it what we want to happen—especially if we put on our future- patient hats? In this regard, there was a recent analysis that concluded that in the cardiac device arena 77 original PMAs accumulated 5839 supplements. More than one-third of the supplements involved a change to a device's design or materials, and in the majority of these cases the supplements were approved without FDA requiring submission of new clinical data. Similar issues are presented in FDA's February 2013 draft guidance on enhancements versus recalls. Here, too, the manufacturer makes the initial decision, and if the decision is, for example, that the withdrawal of one device with replacement by another is not a recall, then FDA receives no direct notification. This kind of decision can have a strong or weak justification, with the basis being primarily patient safety, primarily business interests, or somewhere in between. Of course, business interest is a valid parameter but perhaps not when it overshadows safety considerations. More generally, various field activities may or not be labeled a recall by the manufacturer, and if deemed to not be a recall, FDA need not be notified. Again, this may be a fair assessment or deliberate withholding of information to avoid the recall label and associated tribulations. Medical device reporting can also challenge the system when manufacturers make nonreportable decisions, which by definition means that FDA doesn't directly learn of the associated events. Most rational people agree that there is a right degree of regulatory burden and if that degree is found, manufacturers should fully comply without bending the rules. At some faraway end of the spectrum is the notion that FDA regulations are all burden and no value, and that this justifies finding the quickest and easiest path—even if that involves some creative avoidance. Where do you stand? William A. Hyman is a professor emeritus in the department of biomedical engineering at Texas A&M University and adjunct profes- sor of biomedical engineering at the Cooper Union. 2 The medical device market moves fast. No one understands that like we do. That's why our process is designed with one goal in mind: getting you to market. With proprietary advanced technologies ready for customization, and a collaborative engineering team that understands not only your specs, but your contract, deadlines and budget—it all adds up to one thing: speed. And that's what it takes to be #1. faster. from R&D to o.R. 267.733.0200 x 256 PulseTe ES450936_MD1406_025.pgs 06.03.2014 02:38 UBM black yellow magenta cyan

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