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If a medical device manufacturer intends to bring a product to market in the United States, it must notify the U.S. FDA. This “Premarket Notification” is popularly known as a 510(k) submission, being named after the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that spells out notification requirements.
The U.S. FDA 510(k) submission isn’t the only method available to medical device manufacturers, but it is the most common FDA regulatory pathway. Therefore, it’s important to understand the fundamentals of the process by asking clarifying questions and seeking professional guidance for 510(k) submissions from Kapstone Medical.
Do all medical devices require a 510(k) submission?
A medical device is assigned a risk level based on its potential for compromising patient safety, categorized as Class I, Class, II, or Class III. In turn, that medical device classification determines the need for a 510(k) submission, as follows:
- Class I medical devices are low risk and 510(k) exempt
- Class II medical devices are medium-risk, and most need a 510(k)
- Class III medical devices are high risk and require Premarket Authorization (PMA) or Humanitarian Device Exemption (HDE)
These guidelines apply to the majority of medical devices, but there are some exemptions and exceptions. An experienced medical device consultant is the best resource for accurately evaluating a medical device’s regulatory designation, pathway, and strategy.
How does substantial equivalence factor into the 510(k) pathway?
Substantial equivalence (SE) is central to the 510(k) process. A medical device manufacturer must submit evidence proving that the safety and effectiveness of its new device is at least as good as (or, “substantially equivalent to”) that of a predicate device, being a product that is already on the market.
A device is substantially equivalent in comparison to a predicate if it has:
- The same intended use as the predicate
- The same technological characteristics as the predicate
OR the device:
- Has the same intended use as the predicate
- Has different technological characteristics as the predicate
- Does not raise new questions of safety and effectiveness
- Demonstrates it is at least as safe and effective as the predicate
The new medical device doesn’t have to be identical to the predicate, but there needs to be alignment between the two on certain characteristics.
My internet search turned up several possible predicates. Does it matter which I choose for the 510(k)?
Finding a predicate is a process that may start with a cursory internet search, but selecting the one best suited for 510(k) submission is more nuanced and best done in collaboration with a medical device consultant.
Guidance from a regulatory expert provides access to tools such as device type searches in the U.S. FDA 510(k) database to aid in timely discernment of the appropriate predicate. Such focused selection prevents improper predicate choice that could trigger a more complex U.S. FDA De Novo submission and review depending on the device classification.
Are presubmission meetings mandatory?
A presubmission meeting is voluntary. It is a valuable way to gather information from the U.S. FDA about applicable regulatory requirements and potential deficiencies in the intended 510(k) submission.
Presubmission feedback serves as FDA consulting for medical devices and can be very useful for a manufacturer before submitting a 510(k) and even before completing testing. Any discussion that occurs during a presubmission meeting is documented, but it is in no way considered a binding guidance from the U.S. FDA.
Maximizing the gains from a presubmission can require a lot of effort in compiling the presubmission and asking the right questions in the best way. Collaborating with a medical device regulatory consultant is generally advised to help make the presubmission most effective.
What does the U.S. FDA look for in a 510(k) submission package?
Generally speaking, these are the elements of a 510(k) submission package:
- Indications of Use fall under the selected predicate’s intended use, and define the clinical need for/what a medical device is treating
- Substantial Equivalence (SE) is the focus of 510(k) submissions — using design verification activities such as testing to demonstrate SE to a predicate
- Performance Testing includes any and all bench, animal, and clinical testing as outlined in the design plan
- Biocompatibility may be required depending on the material and the medical device contact with the user/patient
- Electromagnetic Compatibility may be required if the medical device includes electronics, demonstrating overall electrical safety under IEC 60601
- Software Inputs and Outputs need to be verified if the medical device includes a software or is a software
- Proposed Labeling that includes instructions for use, surgical technique guides, and user manuals in addition to the labels on the device and packaging
- Sterilization and Shelf Life Summaries that detail methodologies and results
It’s not uncommon for a device to present unique nuances that need to be addressed in addition to the items on this list, but this overview provides a solid overview of expectations.
What’s eSTAR?
eSTAR is an electronic submission template to facilitate the preparation of 510(k) electronic submissions using:
- Automation (such as form construction and autofill fields)
- Content and structure that complements U.S. FDA internal review templates
- Integration of multiple resources, such as guidances and databases
- Guided direction for each submission section
- Automatic verification
As of October 1, 2023, all non-exempted 510(k) submissions must be submitted electronically using eSTAR.
The U.S. FDA has also recently launched a PreSTAR template which, in many ways, looks and performs like eSTAR. They operate on the same U.S. FDA electronic interface for requesting review and written feedback, with the option for a teleconference.
Professional guidance for U.S. FDA 510(k) submissions
Medical device manufacturers are under great pressure to bring safe, effective products to market. 510(k) submissions are integral to achieving these important goals, but the regulatory pathway to clearance presents challenges.
Partnering with a medical device consultant that delivers depth of experience and a proven track record of successful 510(k) submissions is a smart business decision. Learn more about the process and how Kapstone helps you successfully bring devices to market in our guide, U.S. FDA 510(k): From Concept to Clearance.
