Prior to a company deciding to request a 510(k) clearance from the FDA, months (if not years) are spent designing a product and conducting tests to prove that this new device will function as expected in the intended application. When it is decided to finally seek clearance, all of the relevant information is compiled into an organized packet for the FDA to review.
The required information for this submission includes:
Cover letter – a brief introduction of what the packet contains and the reason for the submission
Table of Contents
510(k) Acceptance Checklist – provided on the FDA website
Statement of Indications for Use – Define the target customers, list specific indications
510(k) Statement or Sumary – summary of the information used to base your claim of substaintial equivalence
Truthful and Accuracy Statement – certify that the information provided is true
Proposed Labeling – include samples of all labels, manuals, instructions, advertising, etc. that is planned for this product
Specifications – include a narrative description and a physical description. The narrative should include indications for use, power source, composition, etc. A physical description includes labeled diagrams, photos, drawings, etc.
Substantial Equivalence Comparison – This new device needs to be compared to a device that is already legally marketed (predicate device). Comparison should include intended use, design, performance, safety, and other applicable characteristics.
Performance – This data includes test results gathered over time. In relation to biological indicators, this will include: stability studies, resistance determinations, population assays, exposure to different temperatures or conditions, use by outside sources, etc.
Additional Requirements, as appropriate
When received by the FDA, a unique identifying number is given to this submission, referred to as the “510(k) number” or “K number”. This consists of seven characters: it begins with the letter “K” followed by six digits. The first two numbers represent the year the submission was received, and the remaining numbers are the sequence of submissions received for that year.
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