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