Building a successful 510(k) submission is something that has baffled people for years. A perfect 510(k) submission will shorten the length of time it takes for your device to enter the market, which is exactly what you should be hoping for with regards to your 510(K) Clearance submission. According to Intertek,  the FDA receives over 3,000 510(k) submissions per year, and this number just keeps on growing!

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So, how long does it take to get a FDA 510k approved? The process can take months if you choose to apply directly to the FDA. However, you can shorten the time period dramatically if you opt for an Accredited Persons organization such as http://www.fdathirdpartyreview.com.

Here are just some of the factors that contribute to a successful 510(k) Submission:

1. 510(k) Cover Sheet

Your submission must include a cover letter, especially if you are electronically submitting your application.

2. Indications for Use

Your submission must include an indication for use statement. It should outline the same indications and those not included with the predicate device.

3. 510(k) Summary

Make sure that your 510(k) statement or summary accurately follows the CFR requirements as noted by the FDA, who will be paying close attention to your summary to ensure you have met the specific requirements.

4. Summary Reports

You need to explain why and how your device embodies certain standards such as safety, performance and effectiveness etc.

5. Device Description

The device description should be pretty detailed and provide technical specifications and information on any included components or accessories. You should also include supporting information and documentation such as electrical schematics, engineering drawings and photographs etc.

6. Substantial Equivalence

This section of your submission is important because it explains why your device is equivalent and must compare important aspects and technical device features etc.

7. Sterilization and Shelf Life

Details of your device’s sterilization and shelf life must be included as part of your 510(k) submission.

8. Biocompatibility

Your submission needs to include biocompatibility elements, referencing FDA standards. Give test results and details about various biological interactions etc.

9. Software

Your 510(k) submission needs to include any relevant software information in connection to your eligible device.

10. Electrical Safety

You will need to include the electrical safety standards of your deice, including an equivalent level of safety to support your findings.