Wednesday, March 27, 2024

 eSTAR 510(k) Submission Elements / Templates:


   Submission Type
   Cover Letter / Letters of Reference 
   Applicant Information 
   Pre-Submission Correspondence and Previous Regulator Interaction 
   Consensus Standards
   Device Description
   Proposed Indications for Use (Form FDA 3881)
   Classification
   Predicates and Substantial Equivalence (includes matrix and discussion)
   Design / Special Controls, Health Risks, and Mitigations (special 
    510(k) only)
   Labeling (labels, IFUs) 
   Reprocessing 
   Sterility
   Shelf Life
   Biocompatibility
   Software / Firmware
   Cybersecurity / Interoperability
   EMC, Electrical, Mechanical, Wireless and Thermal Safety
   Performance Testing
   References (literature, if any)
   Administrative Documentation, e.g., executive summary (recommended), a Truthful and Accuracy   
   Statement, and a 510(k) Summary or Statement) 
   Amendment / Additional Information response (responses to Additional Information requests).\

  Note:  The US 510(k), IDE, De Novo, PMA submission is similar to the EU Technical Document  
  File, in basic content and purpose (proof of meeting regulatory marketing requirements).  

   -- jel@jelincoln.com 








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