How many times have you seen a product boast that it was “FDA approved?” What does that mean? Sometimes a device labeled “approved,” is not approved at all. In fact, the approval process may not have even been necessary for that specific product.
There are four different types of oversight a device can receive from the FDA:
- FDA Cleared – The FDA allows a company to market a product through the 510 (k) process based on substantial equivalence to a preexisting predicate device (see Premarket Notification 510[k] and substantial equivalence below).
- FDA Granted – Used by the FDA to communicate a successful de novo application for market clearance. Roughly equivalent to FDA cleared, but used when substantial equivalence to a preexisting predicate device was not an option.
- FDA Approved – Reserved only for high-risk PMA devices. Devices that do not require a PMA cannot qualify as FDA approved (see Premarket Approval [PMA] below).
- FDA Registered – Your company has paid a fee to notify the FDA you are selling a device; they can come audit you at their discretion. This term communicates no authenticity or FDA goodwill, it merely states the FDA is aware that your company exists.
Beyond the FDA recognition, whether or not a new product can be marketed legally is decided by the Food and Drug Administration (FDA). The FDA is responsible for the filtration of medical devices in the U.S. by setting up a classification system that divides creations into varying degrees of regulation.
There are three levels of medical devices as defined by the FDA, and each one has different regulatory controls:
- Class I medical device – Poses low potential risk, and only provides moderate benefits.
- General controls: Regulations to ensure basic product integrity (labeling standards, records, manufacturing processes, etc.).
- Class II medical device – A higher risk product that requires more serious consideration.
- General controls & special controls: More stringent rules that may involve performance standards, unique labeling requirements, continual surveillance in the post-marketing phase, and more.
- Class III medical device – Products that present an unreasonable risk of harm, but can sustain human life or prevent impairment of human health.
- General controls and Premarket Approval: Must undergo a rigorous examination including clinical trials to be allowed on the market.
To learn more about which classification your device belongs to, go to the FDA’s website and search the FDA classification database for products similar to your own. The goal is to find relevant product codes that will inform you of the regulatory expectations for your specific medical device.
At in2being we have also developed the PathSurveyor tool, which combines multiple FDA resources into the same database making it easy to classify your device, find information on the development requirements, and also get an estimate on the average FDA response time for similar products.
While the FDA is ultimately responsible for classifying your device, doing research can help you chart your own course and get a head start on meeting class-specific requirements.
Premarket Notification 510(k)
For many products marketed in the U.S., a premarket notification 510(k) must be submitted to the FDA to demonstrate substantial equivalence. Substantial equivalence (SE) means the device has similar technological characteristics to previous medical devices that already exist for a similar purpose. A cleared 510(k) shows that a product does what it’s intended to.
A 510(k) premarket notification is required anytime that a new device is being introduced into commercial distribution for the first time or when there is a significant change to a legally marketed product. A significant change is a modification that could substantially affect the device’s safety, effectiveness, or intended use.
The situations in which a 510(k) is NOT required is more difficult to decipher. A 510(k) is not required in the following cases:
- A premarket approval (PMA) is required – medical devices require one or the other, not both.
- You are selling unfinished devices for further manufacturing
- Your device is not being commercially marketed
- You are distributing another firm’s completed device
- If you are merely repackaging or labeling the device
- The device was already being marketed before May 28, 1976 and has not undergone a significant change since. These devices have Pre-amendment Status. Pre-amendment Status is given to devices that were being marketed before rules were passed requiring regulatory approval.
- You import a foreign made device
- Your device is exempted by regulation 21 CFR 862-892.
Once you have established whether or not a 510(k) is necessary for your medical device, the next step is to create the submission.
The FDA has a very specific format that is expected of all premarket notifications. The submissions must be sent in writing to the appropriate FDA center. They must include valid comparisons to similar marketed devices that provide support for their substantial equivalence claims. Until the submitter has received a response from the FDA confirming their device is cleared, they are not allowed to market their device. While the FDA has a 90-day clock for review, the back-and-forth process typically takes longer.
When composing a 510(k) summary, a variety of information must be included, such as:
- The device’s name
- The registration number and device classification
- Actions taken to comply with performance standards
- Potential ideas for labels and advertisements that properly explain a device’s use
- Location the device will be introduced to the market
- A comparison to other similar devices
- A financial certification
- Clinical trial data, if applicable
- Visit the U.S. Food and Drug Administration for a more detailed list of what must be added.
The process of submitting a premarket notification 510(k) to the FDA is equally as important as it is time-consuming. Depending on your device you may be required to abide by the stricter regulations of a Premarket Approval. Either way, the professionals at in2being can interpret expectations and provide valuable advice to make the transition to commercial marketing significantly easier.
Premarket Approval (PMA)
According to the FDA, Class III medical devices are any that “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” These devices require a Premarket Approval (PMA) because of the effect they can have on human life. To earn PMA a device must undergo an FDA review process that examines its safety and effectiveness.
A PMA is necessary for any Class III device that does not already require a 510(k). To find out whether a medical device requires a PMA or a Class III 510(k), the three-letter product code must be searched in the database. The product code is a short identifier that represents the type of device being made and its intended use.
If the code shows up in the Premarket Approval database, it requires a PMA; if it shows up in the 510(k) Premarket Notification database, it requires a 510(k); if the code doesn’t show up in either database and there is no substantially equivalent predicate device, an approved PMA is required before marketing the Class III device in the U.S.
Similar to the 510(k) application, a device cannot be marketed until a PMA is returned from the FDA. The PMA is usually submitted by whoever has access to the data and information about regulatory controls – this can be an individual, corporation, government agency, etc. This application requires the inventor to run clinical trials with humans and laboratory tests in anticipation of the pending approval. The submission must be written in careful consideration of the guidelines, because PMAs will be denied if they are not well-structured and persuasive. The FDA makes the ultimate decision whether or not the data is sufficient enough to send the device to market.
A PMA submission must contain a more detailed description of the Class III medical device and its intended use. Properties relevant to treating a disease or condition, a list of functional components, and the methods of development are just a few more things that must be included. Visit the U.S. Food and Drug Administration for a complete list of the necessary information which must be accounted for in a PMA.
FDA Premarket Approval is no small challenge to acquire. The organization’s intense scrutiny makes it difficult to market a device that is up to FDA expectations. This is yet another place where the knowledge and experience from the in2being team can make a huge difference. These veteran product developers are fluent in the language of regulations and can help communicate what information is essential for the creator to know. in2being’s holistic approach also helps inventors incorporate the design controls during the development process that are necessary to receive a PMA.
When filing for a 510(k), the FDA has the right to reply with a Refuse to Accept (RTA) letter. An RTA letter means that for one reason or another, the organization has decided your submission does not contain sufficient information to even begin the reviewal process. For inexperienced product developers this can happen because there was not a thorough enough device description, the information provided was inconsistent, or there was a lack of testing data.
To avoid having to resubmit because of an RTA letter, inventors should pay close attention to the submission requirements during the development process to be properly prepared. The FDA also has a document on the Refuse to Accept Policy for 510(k)s that guides creators through regulation. This document has a checklist of preliminary questions to answer before submission. It also outlines how the required elements should be organized and presented within the 510(k).
PMAs can be refused for all the same reasons as a 510(k), plus more. The FDA must also see ample data from clinical trials and human testing before approving a PMA for a Class III medical device. If the safety and efficacy of a product is not adequately proven, a PMA will not be granted.
Another roadblock when applying for a PMA is the overall cost. Due to the serious nature of Class III devices and their potential to impact human life, they are significantly more expensive to build and test than Class I and II devices. The application fee for a PMA can run more than $300,000 dollars, while a 510(k) can run more than $10,000. It can be difficult for entry-level inventors to fund this process, which can discourage them from trying in the first place. However, the FDA does offer discounts for small businesses that can reduce the cost.
in2being’s goal is to help device creators understand what is expected of them and how to achieve it. With years of experience designing products to regulatory expectations and navigating the dense language of the FDA, in2being’s team is capable of assisting developers at any stage in the process. Whether you’re just starting or planning on taking things to the next level, reach out to in2being today.