based on
Guidance for Industry and FDA Staff
Format for Traditional and Abbreviated 510(k)s
http://www.fda.gov/cdrh/ode/guidance/1567.html
Title |
Related Information |
Present |
Inadequate |
N/A |
MDUFMA Cover Sheet |
Medical Device User Fee Cover Sheet |
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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 |
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Indications for Use Statement |
Device Advice “ Content of a 510(k)” Section D www.fda.gov/cdrh/devadvice/314312.html#link_6 |
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510(k) Summary or 510(k) Statement |
Device Advice “ Content of a 510(k)” Section E www.fda.gov/cdrh/devadvice/314312.html#link_7 |
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Truthful and Accuracy Statement |
Device Advice “ Content of a 510(k)” Section G www.fda.gov/cdrh/devadvice/314312.html#link_9 |
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Class III Summary and Certification |
Class III Summary and Certification Form |
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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 www.fda.gov/oc/guidance/financialdis.html. |
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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 |
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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 |
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Substantial Equivalence Discussion |
Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3), |
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Proposed Labeling |
Device Advice “ Content of a 510(k)” Section H |
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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” |
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Software |
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
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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 |
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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 |
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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 Certification/Disclosure Forms: Financial Interests and Arrangements of Clinical Investigators www.fda.gov/opacom/morechoices/fdaforms/FDA-3454.pdf www.fda.gov/opacom/morechoices/fdaforms/FDA-3455.pdf |
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Kit Certification |
Device Advice |
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Updated August 1, 2007
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