Product Lifecycle of an IDE by T22m5984

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									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-
    smith@fda.hhs.gov if you have any
    questions.

								
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