When developing medical devices, a manufacturer may have difficulty knowing when (or what) the transition from research phase activities to design controls has begun. Often this is due to the nature of research itself - one is exploring a concept or design approach that may or may not pan out in the end. The US FDA has traditionally applied low scrutiny of medical device research phase activities in an effort to minimize the regulatory burden on the research process. However the manufacturer is obligated to clearly define when research activities have come to a close and design controls (21 CFR 820 . . .
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