Medical Devices
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Screening Checklist for Traditional/Abbreviated Premarket Notification [510(k)] Submissions
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 |
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| 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 |
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| 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 |
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| 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 |
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| 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) |
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| 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 |
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| FORM FDA 3654, Standards Data Report for 510(k)s |
Standards Data Report Form – Form 3654
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| Kit Certification | Device Advice |
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