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You must certify your design...

Just as you certify your income taxes as accurate and correct, you also certify the device complies to all appropriate FDA regulations. The decision is rendered by the FDA's review. If the FDA accepts your data then the FDA accepts your certification. If not then the FDA challenges it. What this means is you must be able to speak authoritatively about development issues and address the FDA regulations that you have determined that apply to your device. The FDA wants to know that you are capable and can produce what you say you can.

Most inventions look at the prototype and consider that the bulk of the task is complete. FDA views that the prototype is the starting point. What the FDA wants is a safe, effective "medical product" that includes labels, instructions, marketing claims, stated performance and the ability to make multiple units.

The FDA will require that you have control. You must declare and establish this. Control could be explained as having control over your own environment. The FDA wants you to create enough drawings and instructions about the "manufacturing" of your device to "fill a box". You place these drawings "in a box" and send them to San Diego and send another identical set of drawings to Kansas City (to different vendors who may have different equipment and different training). Both use your drawings and the materials specified to make units for you. The FDA wants to know that these vendors can ship units to different patients/users who may have slightly different clinical needs but all have sufficient information to use these units and achieve results that will all fall into a same statically predicable "bell curve. "

To accomplish the above consider, the units must be designed with the clinical goal as the primary clinical objective, which means that a host of design controls are in place to create the first working unit. copyright by Compliance Consultants, Stamford, CT USA, September 2001