Contents of FDA 510k Submission for Surgical Face Masks

A 510k clearance is mandatory for surgical face masks to market in the USA. FDA review time for a 510k notification is 3 months, but in actual situation, it may take 6 months or more depends how perfect your 510k documentation is. FDA published guidance documents for surgical face masks 510k submission.

Contents of surgical face masks 510k Notification

  • FDA Form 3601 - Medical Device User Fee Cover Sheet
  • FDA Form 3514 -CDRH Premarket Review Submission Cover Sheet
  • Table of Content
  • 510 k Cover Letter
  • Indications for Use Statement
  • 510 k Summary
  • Truthful and Accuracy Statement
  • Declarations of Conformity
  • Executive Summary
  • Device Description
  • Brief description of manufacturing
  • Substantial Equivalence Discussion
  • Label, Labeling and Advertising
  • Sterilization and Shelf Life
  • Biocompatibility testing
  • Physical property testing

It is always recommended to get assistance of an experienced FDA consultant in 510k documentation and submission, which will help to avoid unnecessary delay in 510k clearance.

LMG can assist you in test requirements, documentation, submission and US Agent service for surgical face mask 510k notification.

FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are examples of surgical face mask 510k clearance.

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