Product Lifecycle of an IDE Design Controls 21 CFR 820.30 Design Control Subsystem Design and Design Development Verification Planning Design Design Input Validation Design Output Design Design Review Changes Design History File Design Controls Purpose Control the design process to assure that devices meet: User needs Intended use Specified requirements Benefits of Design Control Produce higher quality devices by focusing on designing in quality. Recognize problems earlier and make corrections. Enhance degree of conformance of design to the user and patient needs. Applicability Design controls: Are not intended to apply to concept and feasibility studies Apply to devices under Investigational Device Exemption (IDE) Are not retroactive to devices already in distribution prior to June 1, 1997 Questions? Please contact Michelle Noonan- Smith at michelle.noonan- email@example.com if you have any questions.
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