submission 510k submission

A 510(k) submission to the FDA requires a comprehensive set of sections to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. Here are the main sections typically required in a 510(k) submission:

Cover Letter: This letter should include the submission type, the name and address of the manufacturer, and contact information​ (FDA)​​ (FDA)​.

FDA Form 3514: This form provides a summary of the submission contents and is used to ensure all necessary information is included​ (FDA)​.

Table of Contents: A detailed table of contents to help reviewers navigate the submission​ (FDA)​.

Administrative Information:

⦿ 510(k) Summary or Statement: A summary of the safety and effectiveness information or a statement indicating that this information is available upon request​ (FDA)​​ (FDA)​.

⦿ Indications for Use Statement: A clear statement of the device’s intended use​ (FDA)​​ (FDA)​.

⦿ Truthful and Accurate Statement: A declaration affirming the truthfulness of the information provided​ (FDA)​.

⦿ Class III Certification and Summary (if applicable)​ (FDA)​.

Device Description:

⦿ A detailed description of the device, including its components, materials, and intended use​ (FDA)​​ (FDA)​.
⦿ Comparison with Predicate Device: Demonstration of substantial equivalence to a predicate device​ (FDA)​.


Copies of all proposed labels, labeling, and advertisements​ (FDA)​​ (FDA)​.

Performance Data:

⦿ Bench Testing: Results from performance tests conducted in a laboratory setting​ (FDA)​.

⦿ Animal Testing: If applicable, results from animal studies​ (FDA)​.

⦿ Clinical Testing: If applicable, results from clinical trials​ (FDA)​.

Standards and Guidance Documents:

⦿ Declarations of conformity to recognized standards​ (FDA)​​ (FDA)​.
⦿ Summaries or reports demonstrating compliance with specific FDA guidance documents or special controls​​.
Software Validation:

For devices involving software, documentation of software development, validation, and verification processes​​.

Risk Analysis:

A summary of the risk management activities performed for the device​​.

Sterilization Information:

For devices that are supplied sterile, information on the sterilization process and validation​​.

Biocompatibility Information:

Data demonstrating the biocompatibility of the materials used in the device, if applicable​​.

The exact content and format can vary depending on the type of device and the specific guidance documents that apply. For more detailed and device-specific requirements, it’s recommended to refer to FDA guidance documents and the eSTAR template for electronic submissions​.

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