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

Title

Related Information

Present

Inadequate

N/A

MDUFMA Cover Sheet

Medical Device User Fee Cover Sheet
www.fda.gov/oc/mdufma/coversheet.html

CDRH Premarket Review Submission Cover Sheet

CDRH Premarket Review Submission Cover Sheet
www.fda.gov/opacom/morechoices/fdaforms/FDA-3514.pdf

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 www.fda.gov/cdrh/devadvice/314312.html#link_6

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

Truthful and Accuracy Statement

Device Advice “ Content of a 510(k)” Section G www.fda.gov/cdrh/devadvice/314312.html#link_9

Class III Summary and Certification

Class III Summary and Certification Form
www.fda.gov/cdrh/manual/stmnciii.html

Financial Certification or Disclosure Statement

FORM FDA 3454, Certification: Financial Interests and Arrangements of Clinical Investigators
www.fda.gov/opacom/morechoices/fdaforms/FDA-3454.pdf

FORM FDA 3455, Disclosure: Financial Interests and Arrangements of Clinical Investigators
www.fda.gov/opacom/morechoices/fdaforms/FDA-3455.pdf

Financial Disclosure by Clinical Investigators www.fda.gov/oc/guidance/financialdis.html.

Declarations of Conformity and Summary Reports (Abbreviated 510(k)s)

Use of Standards in Substantial Equivalence Determinations
www.fda.gov/cdrh/ode/guidance/1131.html.

FDA Standards program
www.fda.gov/cdrh/stdsprog.html.

Declaration of conformity
www.fda.gov/cdrh/devadvice/3145.html#link_9

Required Elements for Declaration of Conformity to Recognized Standard
www.fda.gov/cdrh/ode/reqrecstand.html

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),
www.fda.gov/cdrh/k863.html

Proposed Labeling

Device Advice “ Content of a 510(k)” Section H
www.fda.gov/cdrh/devadvice/314312.html#link_10

Sterilization/Shelf Life

Updated 510(k) Sterility Review Guidance (K90-1)
www.fda.gov/cdrh/ode/guidance/361.html

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
www.fda.gov/cdrh/ode/guidance/1216.html

Biocompatibility

FDA Blue Book Memo, G95-1, Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing”
www.fda.gov/cdrh/g951.html

Software

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
www.fda.gov/cdrh/ode/software.html

Electromagnetic Compatibility/Electrical Safety

CDRH Medical Device Electromagnetic Compatibility Program
www.fda.gov/cdrh/emc

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

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

Kit Certification

Device Advice

http://www.fda.gov/cdrh/devadvice/314c.html