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Product Lifecycle of an IDE

Product Lifecycle of an IDE. Design Controls 21 CFR 820.30. Design and Development Planning Design Input Design Output Design Review. Design Verification Design Validation Design Changes Design History File. Design Control Subsystem. Design Controls Purpose.

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Product Lifecycle of an IDE

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  1. Product Lifecycle of an IDE Design Controls 21 CFR 820.30

  2. Design and Development Planning Design Input Design Output Design Review Design Verification Design Validation Design Changes Design History File Design Control Subsystem

  3. Design ControlsPurpose • Control the design process to assure that devices meet: • User needs • Intended use • Specified requirements

  4. 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.

  5. 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

  6. Questions? • Please contact Michelle Noonan-Smith at michelle.noonan-smith@fda.hhs.gov if you have any questions.

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