510k Submission

IF YOUR MEDICAL DEVICE COMPANY IS BUILDING A CLASS I, II OR III MEDICAL DEVICE THAT DOES NOT REQUIRE PRE-MARKET APPROVAL, YOU'LL HAVE TO PREPARE A 510K SUBMISSION FOR THE FDA IN ACCORDANCE WITH 21 CFR PART 807.

The 510k submission process is a paperwork submission that many medical devices get wrong, resulting in expensive re-submission attempts and longer times to market. The purpose of a 510k submission is to demonstrate that your medical device is substantially equivalent, meaning at least as safe and effective, as an existing medical device on the market today that does not require a premarket approval (PMA).

WHO MUST COMPLETE A 510K SUBMISSION?

The FDA is very specific about its requirements for who must submit a 510k. Rather than identifying who should submit the documents, it details which 4 actions should trigger a 510k submission:

1. Domestic manufacturers introducing a device to the U.S. market must submit a 510k.
2. Specifications developers who want to outsource manufacturing for a device that will be marketed in the U.S. must submit a 510k. The specification developer is responsible for this, not the manufacturer.
3. Re-packers or re-labelers that make labeling changes, or whose operations significantly affect the device, must complete a 510k submission before marketing their product in the U.S.
4. Foreign manufacturers/exporters introducing a device to the U.S. market must complete a 510k submission.

WHAT IS SUBSTANTIAL EQUIVALENCE?

Substantial Equivalence is the key point of 510k submissions - manufacturers must show that their medical device is sufficiently similar to a predicate device while being at least as safe and effective.

A device is substantially equivalent if, in comparison to the predicate, it has the same intended use and has the same technological characteristics OR has the same intended use with different technological characteristics, and the information submitted to the FDA demonstrates that it is at least as safe and effective as the legally marketed device. Manufacturers that have successfully proved substantial equivalence will have their submissions published on the FDA 510(k) database. 

WHAT BELONGS IN A 510K SUBMISSION?

The number one source of confusion about 510k submissions comes from the fact that there's no "510k form" that you simply fill out and send to the FDA. The guidelines for 510k submissions are set out in 21 CFR Part 807, and you'll have to view the FDA's specific requirements to ensure you're not missing anything. The good news is that Greenlight Guru's QMS Software is designed to securely store all of the data on your medical device that you'll need to submit for your 510k, including:

• Indications for Use
• Classification of the device (see here for more on how to classify your device)
• Description of the device, including specifications, and referencing applicable guidance documents, special controls or standards, photographs or engineering drawings (these should come from your design controls folder)
• Comparison with a predicate device
• Intended use of the device (should be documented early on, along with user needs)
• Proposed label, labeling, and advertisements for the device (get past these 3 common misconceptions about labeling first)
• Information on sterilization, biocompatibility, expiration date, etc.

Greenlight Guru’s QMS Software is the industry-leading quality management system that streamlines the 510k submission process and helps you get to market faster. With photographs, drawings, labels, device specifications, intended use, and indications already documented, you're just a few steps away from a successful 510k submission process that will allow you to market your medical device in the U.S.