510(k) Submission Checklist

CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)

Required for all 510(k) submissions. Complete all applicable fields including device name, product code, applicant information.

Ref: FDA eCopy Program

Cover Letter

Identify the submission type (Traditional, Special, or Abbreviated 510(k)), device trade name, common name, classification name, product code, classification panel, and contact information for the submission holder.

Ref: 21 CFR 807.87

Indications for Use Statement (FDA Form 3881)

Complete the standard FDA form. Include intended use, indications for use, and prescription/OTC designation. This statement must match the predicate or clearly define any differences.

Ref: 21 CFR 807.87(e)

510(k) Summary or 510(k) Statement

Either a 510(k) Summary (per 21 CFR 807.92) that will be made publicly available, or a 510(k) Statement (per 21 CFR 807.93) certifying that safety/effectiveness information will be provided upon request. Most submitters choose the Summary.

Ref: 21 CFR 807.92 / 807.93

Truthful and Accurate Statement

Signed statement per 21 CFR 807.87(k) certifying that all information is truthful and accurate and no material fact has been omitted.

Ref: 21 CFR 807.87(k)

Class III Summary and Certification (if applicable)

For Class III devices where 510(k) is accepted (pre-amendments devices), include the Class III certification per 21 CFR 807.87(l).

Financial Certification or Disclosure (if clinical data included)

Per 21 CFR Part 54, disclose financial interests of clinical investigators if clinical data is submitted.

Ref: 21 CFR 54

Device Description

Detailed description of the device including physical characteristics, materials, dimensions, principles of operation, power source, accessories, and all device variants/configurations included in the submission.

Tip: Include annotated photographs, engineering drawings, and block diagrams. Clearly distinguish the subject device from accessories.

Substantial Equivalence Comparison

Side-by-side comparison table of subject device vs. predicate device(s). Address: intended use, indications for use, technological characteristics (materials, design, energy type, software), performance specifications.

Tip: Highlight similarities and differences explicitly. For each difference, explain why it does not raise new questions of safety or effectiveness.

Non-Clinical Performance Testing

Bench testing, mechanical testing, electrical safety and EMC testing, shelf life/packaging studies. Include test protocols, acceptance criteria, results, and conclusions.

Tip: Use recognized consensus standards where available (IEC 60601, ASTM, ISO). Reference the specific standard edition tested to.

Biocompatibility

Biological evaluation per ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1." Determine required endpoints based on body contact type and contact duration. Include material characterization data.

Tip: A biocompatibility risk assessment may reduce testing requirements if materials are well-characterized and have a history of safe use.

Software Documentation

Per FDA guidance "Content of Premarket Submissions for Device Software Functions" (2023): software description, risk assessment, documentation at the appropriate level (Basic/Enhanced/Comprehensive), cybersecurity documentation, SBOM.

Ref: IEC 62304; FDA Software Guidance (2023)

Sterilization and Shelf Life (if applicable)

Sterilization validation (ISO 11135, 11137, 11137-2), sterility assurance level (SAL), package integrity testing (ISO 11607), accelerated or real-time aging data.

Clinical Data (if applicable)

Clinical study data, clinical literature review, or clinical experience data. Include study protocol, patient demographics, results, adverse events, and statistical analysis. Required when bench testing alone cannot demonstrate SE.

Ref: 21 CFR 807.87(h)

Labeling

All proposed labeling: device label, packaging, instructions for use (IFU), physician/clinician manual. Must comply with 21 CFR 801 general labeling requirements and 21 CFR 809 (IVD labeling, if applicable).

Tip: Include UDI on labels per 21 CFR 830. Ensure labeling is consistent with the Indications for Use statement.

Declarations of Conformity to Recognized Standards

For each recognized consensus standard used, provide an FDA-accepted Declaration of Conformity. List the specific standard edition and any deviations. See FDA's Recognized Consensus Standards database.

Summary of Compliance with Special Controls (if Abbreviated 510(k))

For Abbreviated 510(k) submissions, provide a summary report demonstrating conformance with the applicable special controls guidance document or recognized standards.