Anyone who wants to market medical devices or many other devices intended for human use in the US must be familiar with 510(k) and the FDA. What is 510(k) and who is FDA? What do international businesses, especially those in Vietnam, need to know about 510(k) to successfully enter the US market? Noble Network’s newsletter this month will provide our readers with the answers by explaining about 510(k) in more detail.

Who is the FDA and what’s 510(k)?

FDA, or the US Food and Drug Administration, is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

Each person who wants to market devices intended for human use in the U.S, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.

What’s SE (substantial equivalence)?

It’s a demonstration that a new device has, in comparison with a predicate device, 

• the same intended use
• the same technological characteristics, OR, differences in technological characteristics do not raise different questions regarding its safety and effectiveness.

 What’s a predicate device?

A predicate device is a device that either 1) was legally marketed prior to May 28, 1976 (pre-amendment device), 2) a device that has been reclassified from Class III to Class II or I, 3) a device that has been found SE through the 510(k) process, or 4) a device that was granted marketing authorization via the De Novo classification process.

How to evaluate SE?

FDA first establishes that the new and predicate devices have the same intended use and any differences in technological characteristics do not raise different questions of safety and effectiveness. 

 

FDA then determines whether the device is as safe and effective as the predicate device by reviewing the scientific methods used to evaluate differences in technological characteristics and performance data. This performance data can include clinical data and non-clinical bench performance data, including engineering performance testing, sterility, electromagnetic compatibility, software validation, biocompatibility evaluation, among other data.

Types of 510(k) submission

There are 3 types of 510(k) submission: Traditional, Abbreviated, and Special. 

The Traditional 510(k) Program can be used under any circumstance to seek marketing authorization of a device through the 510(k) Program. The Special 510(k) and Abbreviated 510(k) submission types can be used when a 510(k) submission meets certain factors. 

Often, Vietnamese businesses are only eligible for the traditional 510(k) submission.

The content of Traditional 510(k) submission:

There are 10 elements of a traditional 510(k) submission:

• General information
• Table of contents
• 510(k) Acceptance Checklist
• Statement of Indications for use
• 510(k) Summary or Statement
• Truthful and Accurate Statement
• Proposed Labeling
• Specifications
• Substantial Equivalence Comparison
• Performance

 

More information on each of these elements and the submission process will be covered in our next month’s newsletter.