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Key Components of a Traditional 510(k) Submission

Assembling Your 510(k) Submission

A well-prepared 510(k) includes essential sections like device description, predicate comparison, performance data, and labeling. Using FDA’s eSTAR template and RTA checklist helps ensure completeness and avoid delays.

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Assembling a complete 510(k) is as important as the scientific content itself. The FDA uses a Refusal to Accept (RTA) checklist to screen submissions for administrative completeness. Incomplete or disorganized packages result in rejection and delays. A structured approach—including the FDA’s eSTAR template and eCopy format—helps ensure your submission meets all requirements. 

Cover letter and administrative information Your cover letter introduces your company, names the device, lists the product code and regulation number, identifies the predicate and states whether the submission is traditional, special or abbreviated. Include a 510(k) number if resubmitting or referencing prior submissions. Provide contact information for the regulatory correspondence.
510(k) summary or statement A summary is a concise description of the device, intended use and significant technological characteristics. A 510(k) statement certifies that safety and effectiveness information will be furnished to any person upon written request, as required by 21 CFR 807.92.
Indications for use Use Form 3881 to describe the device’s intended use, indications, patient population and anatomical site. Consistency with the device description, labeling and marketing materials is critical
Device description Provide comprehensive details on design, dimensions, materials, energy sources, software/firmware, accessories, and components. Include block diagrams, photographs and drawings that illustrate how the device operates.
Predicate comparison Create a table comparing intended use, design, materials, energy sources, performance, biocompatibility and labeling between your device and the predicate. Explain differences and justify why they do not raise new safety or effectiveness questions.
Performance testing Summarize all verification and validation testing—bench tests, animal studies and, if needed, clinical data. Include protocols, acceptance criteria and results. The FDA rarely accepts promissory commitments to complete testing later. Common tests include biocompatibility, sterilization, shelf life, electrical safety and performance testing.
Risk management Include your risk analysis (e.g., ISO 14971). Identify hazards, estimate risk levels and describe mitigations. Provide traceability between identified hazards and verification and validation activities.
Biocompatibility and sterilization If the device contacts the body, provide biocompatibility data per ISO 10993 and sterilization validation or rationale for non‑sterile devices. Describe packaging validation and shelf life testing to support claimed expiration dating.
Labeling Attach draft labels, instructions for use, operator manuals and packaging artwork. All labeling must be consistent with the indications for use.
Recognized standards and declarations of conformity Identify any consensus standards used (e.g., IEC 60601‑1 for electrical safety) and provide declarations of conformity if applicable.

Using the eSTAR interactive PDF ensures you include all necessary sections and formatting requirements. Before submission, perform an internal RTA checklist review to verify completeness. A well‑organized submission reduces the likelihood of rejection and facilitates an efficient substantive review. 

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