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Everything in Details About 510(k) Submission


If you are running a drug and medical device business, then it is essential you know about the guidelines behind 510(k) submission. IF you are manufacturing a Class I, II, or III levels medical device without any pre-market approval, you must prepare the submission form for 510(k) to the FDA. It is also in accordance with Part 807 of 21 CFR. You must prepare an error-free 510(k) submission form, or else your application may be rejected, and the re-submission process to FDA is very much time consuming and expensive at the same time.

Who Should Submit:

FDA is the watchdog of quality drugs and medical equipment in the American market, so you must be very careful to follow all their rules and norms while preparing your 510(k) submission form. They also have guidelines against the companies that can apply for the submission form.

  • Domestic medical manufacturers who want to launch a medical device should apply for an FDA 510(k) submission form.
  • Foreign marketers/exporters intending to launch their medical products should also follow the above guidelines.
  • Re-packers who change the name of a specific device in the US should submit 510(k) before launching their product.
  • Outsourcing manufacturers should also apply for a 510(k) submission form before launching a medical product to the American market.

What to Mention:

When you submit a 510(k) form to the FDA, you must remember that you have to specify all the medical device’s features and descriptions. You must recheck the form twice and make sure that not a single information is missing from your application. Here is a list of some essential parts which must be reflected on your FDA 510(k) submission form.

  • Indications of using the device
  • Classifications of the device
  • Comparison of the concerned device with another predicative device
  • Description of the device which includes specifications, referencing, and special control of standards
  • Proposed labeling and advertising method of the device
  • Information on sterilization, expiry date, whether it is a bio-waste.
  • The intention of the usage of the device

This information is enough to add in your 510(k) submission form to FDA. Make sure that all the points mentioned above are included in your form. Based on these critical observations, the approval of your FDA certification will be judged.

Substantial Equivalence:

This is one of the essential parts you need to add to your FDA 510(k) submission form. You must show the FDA that your medical device is similar to predictive medical equipment that is safe to use and useful to the disease it is supposed to combat. If your device has the same technological characteristics as another device or has the same types of usages, you must also mention that. If it does not have the same technical aspects, but the intended use is the same, you can also mention that. The substantial equivalence is essential to mention in your 510(k) form. It will make a point for your device and will act as a readily available reference.


The 510(k) submission form is not only necessary to provide to the FDA, but it will also act as a certificate of originality for your medical device. We have discussed the most critical facts that are needed for a 510(k) form submission. You need to remember these main things before submitting your 510(k) form to the FDA. Just add all the relevant information regarding your medical device and be confident of getting the approval within a short time.


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