Medical devices in the US (and the rest of the world) use a risk-based classification system that determines the rules and regulations and level of evidence necessary to obtain FDA permission to market a new or modified medical technology.
In the US, the precise terminology of FDA cleared vs. approved arises from the statutory distinction between a sponsor marketing a Class II 510(k) vs. Class III PMA medical device. FDA marketing terminology for products that are Class I 510(k) Exempt is the same as with Class II 510(k)s — that is “FDA Cleared”.
For De Novo 510(k)s, it’s not clear what terminology sponsors should use. A quick search of recent listings in FDA’s De Novo 510(k) database indicates that some sponsors on their websites describe a newly marketed De Novo 510(k) technology as “FDA approved” while others use the more conservative terminology of “FDA cleared”.
Interestingly, the real-world implications of using incorrect terminology — for example inappropriately claiming that a Class II 510(k) device is “FDA approved” — while not advisable rarely results in a publicly disclosed FDA compliance enforcement action such as a Warning Letter.
1976 Medical Device Amendments to FD&C Act
The precise terminology of FDA-cleared vs. approved dates back to the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act (FD&C Act) which for the first time established a statutory framework designed specifically for FDA regulation of medical devices as opposed to FDA oversite of pharmaceuticals, dietary supplements, veterinary products, etc.
Pathway to Market for Medical Devices – 510(k) and PMA
The statutory framework of the Medical Device Amendments established 2 Pathways to Market for new or modified medical technologies:
|Statutory Provision||Common Name||Risk Classification||Regulatory Paradigm|
|Premarket Notification||510(k)||Class II — Moderate||Substantial Equivalent (SE) to Predicate Device|
|Premarket Approval||PMA||Class III — High||Reasonable Assurance of|
Safety and Effectiveness
1. FDA Premarket Notification – 510(k) Submission
The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance.
Under section 510(k) of the FD&C Act, a manufacturer must submit a 510(k) to FDA at least 90 days before introducing or delivering for introduction, a device into interstate commerce for commercial distribution so the Agency can determine whether or not the device meets the criteria for market clearance.
If FDA finds the device to be substantially equivalent, the sponsor receives an order, in the form of a letter, from FDA which states that the device can be legally marketed. This order “clears” the device for commercial distribution in the US.
2. FDA Premarket Approval – PMA Submission
The Premarket Approval or PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device.
PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
Marketing via FDA Clearance vs. FDA Approval
The 1976 Medical Device Amendments established different terminology for marketing 510(k) vs. PMA technologies as specified below. Using different languages suggests that there is a purposeful distinction between whether a new medical device comes to market via the 510(k) vs. PMA Regulatory Pathway.
|Marketing Application||Safety and Effectiveness Testing Requirements for Marketing|
|FDA 510(k)||To obtain FDA Clearance, the manufacturer must compare the new device to a similar legally marketed predicate device and demonstrate substantial equivalence.|
|FDA PMA (Pre-Market Approval)||To obtain FDA Approval, the manufacturer must provide sufficient testing results from the new device that demonstrate a reasonable assurance of safety and effectiveness.|
In fact, there is no legal or commercial difference between whether a medical technology comes to market through FDA Clearance or FDA Approval.
In both cases, what’s important is that FDA acknowledges in writing (SE Letter vs. PMA Approval Order) that the manufacturer can introduce a new or modified medical device into commercial distribution.
De Novo 510(k)s
1. Language from Sponsor Websites
For De Novo 510(k)s, it’s not clear what terminology the sponsor should use. A quick search of recent listings in FDA’s De Novo 510(k) database indicates that some sponsors on their websites describe a newly marketed De Novo 510(k) technology as “FDA approved” while others use the more conservative terminology of “FDA cleared”. The following are examples of newly marketed De Novo 510(k) devices. One company website specifies FDA approved and the other FDA cleared.
|Neurolutions IpsiHand |
Upper Extremity Rehabilitation
Apple Watch App for PTSD
2. Regulatory Paradigm for De Novo 510(k)s is Most Similar to PMA, Not Traditional 510(k)
Unlike traditional 510(k)s and PMAs, the De Novo Letter that sponsors receive from FDA allowing them to market a new device does not include terminology such as “FDA cleared” or “FDA approved”.
Instead, the De Novo Letter provides the following boilerplate language:
“After review of the information submitted in the De Novo request, FDA has determined that … [your device] can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.”
According to the above, the regulatory paradigm for the De Novo 510(k) pathway to market is very similar to the PMA – that is for the sponsor to demonstrate a reasonable assurance of safety and effectiveness.
3. So What Terminology Should a Sponsor Use?
Since a PMA sponsor appropriately refers to their marketed device as “FDA approved”, the above Regulatory Analysis provides the sponsor of a De Novo 510(k) ample justification to use the same language for marketing their medical device.
So De Novo 510(k) sponsors can confidently use “FDA approved” as appropriate terminology for product Websites, Advertising, and Promotional Materials, Sell Sheets, etc.
Real World Implications of Using Incorrect Terminology
The real-world implications of using incorrect terminology (FDA cleared vs. FDA approved) are surprisingly low risk — even considering regulatory and/or legal liability.
FDA clearly has the authority to determine if a medical device is “misbranded”. This is most commonly the result of some aspect(s) of product labeling which is found by the FDA to be false or misleading.
2. Labeling for 510(k) Device Incorrectly Specifies “FDA Approved”
What are the consequences if a sponsor (either inadvertently or perhaps intentionally) incorrectly claims that a Class II 510(k) device is “FDA approved”?
According to the letter of the law, this would qualify as misbranding. But the real-world consequences are actually insignificant.
FDA’s Compliance and Quality Staff is a relatively small group with limited resources. When a product is found to be misbranded, FDA typically pursues enforcement action only if the violation meets either of the following:
- Misbranding could reasonably result in patient harm
- Misbranding characterizes device therapy as more effective than was demonstrated in 510(k) submission
3. Warning Letter From FDA – Compliance Enforcement Action
FDA typically reserves the use of a Warning Letter for compliance violations that meet one of the following – in order from most common to least:
- Noncompliance with Quality Systems Regulation (QSR)
- Class II Device has been marketed without 510(k) filing
- Failure to properly conduct Postmarket Surveillance
In FDA’s Warning Letter database, there are no instances of misbranding from using incorrect marketing status terminology.
So while not advisable, simply misbranding a Class II 510(k) device by using the incorrect terminology of FDA approved (as opposed to FDA cleared) would rarely if ever result in a compliance enforcement action such as FDA issuing a Warning Letter.
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