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U.S. Department of Health and Human Services

Medical Devices

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Screening Checklist for Traditional/Abbreviated Premarket Notification [510(k)] Submissions

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Screening Checklist for Traditional/Abbreviated Premarket
Notification [510(k)] Submissions

based on
Guidance for Industry and FDA Staff
Format for Traditional and Abbreviated 510(k)s
Title

Related Information

Present

Inadequate

  N/A  

MDUFMA Cover Sheet Medical Device User Fee Cover Sheet      
CDRH Premarket Review Submission Cover Sheet CDRH Premarket Review Submission Cover Sheet

 

   
510(k) Cover Letter Appendix A of "Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s" updated November 17, 2005      
Indications for Use Statement Device Advice "Content of a 510(k)" Section D      
510(k) Summary or 510(k) Statement Device Advice "Content of a 510(k)" Section E      
Truthful and Accuracy Statement Device Advice “Content of a 510(k)” Section G      
Class III Summary and Certification Class III Summary and Certification Form      
Financial Certification or Disclosure Statement FORM FDA 3454, Certification: Financial Interests and Arrangements of Clinical Investigators
FORM FDA 3455, Disclosure: Financial Interests and Arrangements of Clinical Investigators
Financial Disclosure by Clinical Investigators
     
Declarations of Conformity and Summary Reports (Abbreviated 510(k)s) Use of Standards in Substantial Equivalence Determinations
FDA Standards program
Declaration of conformity
Required Elements for Declaration of Conformity to Recognized Standard
     
Executive Summary See section 10 in Chapter II of “Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s” updated November 17, 2005      
Device Description See section 11 in Chapter II of “Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s" updated November 17, 2005      
Substantial Equivalence Discussion Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3)      
Proposed Labeling Device Advice “ Content of a 510(k)” Section H      
Sterilization/Shelf Life Updated 510(k) Sterility Review Guidance (K90-1)
For reuse of single use devices, see Guidance for Industry and FDA Staff – Medical Device User Fee and Modernization Act of 2002 Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
     
Biocompatibility FDA Blue Book Memo, G95-1, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"      
Software Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices      
Electromagnetic Compatibility/Electrical Safety CDRH Medical Device Electromagnetic Compatibility Program
See also IEC 60601-1- 2 Medical Electrical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests (Second Edition, 2001)
     
Performance Testing – Bench See section 18 in Chapter II of "Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s" updated November 17, 2005      
Performance Testing – Animal See section 19 in Chapter II of "Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s" updated November 17, 2005      
Performance Testing – Clinical

See section 20 in Chapter II of "Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s" updated November 17, 2005

FORM FDA 3454, Certification: Financial Interests and Arrangements of Clinical Investigators

FORM FDA 3455, Disclosure: Financial Interests and Arrangements of Clinical Investigators 

     
FORM FDA 3654, Standards Data Report for 510(k)s

Standards Data Report Form – Form 3654

  1. No standard used - No Standards Form Required
  2. Declaration of Conformity – Yes Standards Form Required
  3. Standard but no declaration – Yes Standards Form Required
     
Kit Certification Device Advice      
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