A few people (you know who you are) have been wanting to work on new or cost-improved medical devices at BUGSS. What about lowly makers who just want to build (or maybe sell) a fun little piece of medical hackerware? Well, here, at last, is someone who can give us the skivvy on what it takes to actually offer new medical (or diagnostic) devices for sale. Blix Winston is a local consultant who shepherds medical device dreams through the FDA regulatory process. In Blix's words:
"FDA’s establishment registration requirement has to be met once a medical device is offered for sale in the U.S. but there are other requirements that come into play well before registration occurs. Obtaining marketing clearance or approval may be needed but there is a less obvious requirement that many start-up companies miss as they begin to develop their ideas into prototypes or working models; it is a part of the Quality Systems, or GMP, regulation. GMPs are usually thought of as applying to production processes which of course they do. But the Design Controls portion of the Quality Systems regulation applies as soon as you start conceptualizing or discussing a new device or start making even the most rudimentary drawings. Failing to develop and implement Design Controls at the outset can cause headaches later on."
"Navigating the FDA regulatory process can turn into a costly process both in terms of resources and time. To minimize those costs it helps to develop a basic understanding of how the regulatory process works so that you can anticipate and plan for what is coming and how it will affect your company. In this evening’s session I’ll take you through an outline of the regulatory process starting with how FDA classifies medical devices. Classification determines the regulatory pathway and is key to everything from planning the kinds and amount of resources you are going to need, deciding whether clinical trials may be in the picture, planning for and obtaining FDA permission to go to market, determining if GMPs apply to your device, etc. I’ll share the knowledge I’ve developed through 30 years of working in FDA, teaching FDA regulatory requirements at the graduate and corporate level, and consulting to the medical device industry both here and abroad. My intention is to have an interactive meeting rather than a formal presentation format."
Everyone welcome Wednesday, July 16th at 7 pm. FREE of course. You're free to bring your ideas on whatever new-fangled medical quackery you can come up with. RSVP here!
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