Medical device materials undergo physical and chemical changes during total product life cycle (TPLC). Some examples:

  • chemical reactions, separation/purification, temperature excursions
  • microstructure changes, molding/extrusion, weaving
  • 3D printing

Novel Materials and Manufacturing Research Program elucidates 

  • TPLC findings
  • Relationship to Safety and Effectiveness (S&E) of device
  • How seemingly minor manufacturing changes can lead to S&E changes


Image credit: FDA

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