Hi friends!!!

In our previous blogs, we have discussed about the following topics.

In today’s blog, we will explore about 510(k) submission, its requirements, its importance of demonstrating substantial equivalence & how it impacts the medical device industry. Whether you’re a startup or established manufacturer, understanding the 510(k) is vital for ensuring regulatory compliance and bringing your product to the market

It is also important for Medical Device QA/RA Professionals to know in detail about 510(k).

Let’s get into the topic.

Premarket Notification 510(k)

Every domestic manufacturer, specification developers, foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters trying to market their device in US shall submit 510(k). This will also be applicable for repackers or relabelers who make labeling changes or whose operations significantly affect the device. Therefore, it is very important for above mentioned stakeholders to know in detail about 510(k) submission.

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What is Premarket Notification 510 (k)?

A 510(k) is a premarket submission made to FDA which requires you to demonstrate that your medical device is substantially equal to the another legally US marketed device. Substantial equivalence shall be demonstrated by proving that your medical device is as safe and effective as the predicate device.

The term “Predicate” is used to represent the medical device(s) legally marketed in US, to which equivalence is drawn during the 510(k) submission.

The question of your medical device’s substantial equivalence shall be based on the following criteria:

The first criteria to claim substantial equivalency to the predicate medical device is that your device has same intended use as compared to the predicate medical device and it has the same technological characteristics as compared to the predicate medical device.

The second criteria to claim substantial equivalency to the predicate medical device is that your device has same intended use as compared to the predicate medical device and even if your device has a different technological characteristic, it shall not raise different questions related to the safety and effectiveness and the information submitted to FDA shall demonstrate that your device is as safe and effective as the legally marketed predicate medical device.

Product Codes:

The Product codes are Three letter codes used by FDA to identify and track similar medical devices

The Product codes are used by 510(k) submitters to search for a predicate device(s) to prove substantial equivalence. The Product codes can be found on most of the 510(k) clearance letters.

Types of 510(k) Submission:

Traditional 510(k)

The Traditional 510(k) relies on demonstrating substantial equivalence. The Traditional 510(k) can be used under any circumstances.

Abbreviated 510(k)

The Abbreviated 510(k) relies on the use of recognized standards, special controls and guidance documents. Under certain conditions, the submitter or sponsor shall not need to submit the test data.

Special 510(k)

The Special 510(k) shall be submitted in case of modifications to manufacturers own legally marketed device. Data is not evaluated by FDA.

The following are the questions that needs to be answered to attain eligibility for Special 510(k) Submission:

Is there any change to the manufacturer’s own legally marketed medical device?

Are performance data needed to evaluate the change?

Are there any methods which are well-established to evaluate the change?

Can the medical devices data be reviewed in a summary or risk analysis format?

If answers to all the above questions falls under Yes category, then your modifications to the device shall be reviewed as Special 510(k).

Contents of 510(k) Submission:

The following are the important information that needs to be submitted during 510(k), but are not limited to:

Indications for use.

510(k) Summary.

Declaration of conformity & guidance documents.

Device Description.

Substantial Equivalence Discussion.

Proposed Labelling.

Performance Testing – Bench.

Performance Testing – Animal.

Performance Testing – Clinical.

Now I hope you have acquired some basic knowledge about the requirements of 510(k). We will meet again with another valuable topic related to MedTech Quality & Regulatory, Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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