When the FDA says a medical device is cleared versus approved, it is describing two legally distinct decisions. A cleared device made it to market by showing it is substantially equivalent to a device already sold in the United States. An approved device made it to market by submitting original clinical evidence that FDA scientists reviewed independently to confirm the product is safe and effective on its own merits. Both labels mean the device is lawfully on the market, but the FDA looked at very different things to get there, and that is the core of FDA cleared vs. approved.
What “Cleared” Means
Clearance comes out of the 510(k) premarket notification process. The manufacturer identifies an already-cleared device, called a predicate, and demonstrates that its new product is substantially equivalent to that predicate. Substantial equivalence means the new device has the same intended use and either shares the predicate’s technological characteristics or, if it differs, the differences do not raise new questions about safety or effectiveness.1eCFR. 21 CFR Part 807 Subpart E – Premarket Notification Procedures
The comparison is granular. A manufacturer building a new pulse oximeter, for example, lines its device up against the predicate on intended use, materials, design, energy source, and performance specifications. Where the two devices differ technologically, the manufacturer carries the burden of showing those differences do not create new safety or effectiveness concerns, sometimes with bench studies, performance testing, or limited clinical data.
What clearance does not involve is an independent FDA finding that the device is safe and effective from scratch. The agency does not run new clinical trials or its own laboratory testing. It concludes the device is close enough to a product whose safety profile it has already accepted. At the end of a roughly 90-day review, the FDA issues one of two determinations: substantially equivalent, which is the clearance letter and allows immediate marketing, or not substantially equivalent, which automatically pushes the device into Class III.1eCFR. 21 CFR Part 807 Subpart E – Premarket Notification Procedures
Clearance is designed for incremental improvements to established technology. A new version of a blood pressure cuff does not need to prove from scratch that measuring blood pressure is useful. It needs to prove it measures blood pressure at least as well and as safely as the cuff already on the shelf.
What “Approved” Means
Approval comes out of the Premarket Approval (PMA) process, which the FDA reserves for its highest-risk devices. Here the manufacturer is not comparing its product to anything. It is submitting original evidence that the device is safe and effective for its intended use, and the FDA’s own physicians, engineers, and statisticians review that evidence in depth.2U.S. Food and Drug Administration. Premarket Approval (PMA)
The backbone of a PMA is clinical data from human studies. For medical devices, this typically means a feasibility study confirming the device works as designed, followed by a larger pivotal study generating statistically significant evidence of safety and effectiveness. Non-clinical data fills in the rest: biocompatibility, toxicology, stress testing for physical durability, and software verification where applicable. Every adverse event and complication observed during the clinical work must be disclosed. The FDA expects the record to show that the device’s probable benefits outweigh its probable risks for the intended patient population.
The review often includes an Advisory Committee panel, a public meeting where independent experts examine the evidence and make a recommendation. Federal law requires the FDA to act on a PMA application within 180 days of receipt, though the clock often pauses when the agency requests more information.3Office of the Law Revision Counsel. 21 USC 360e – Premarket Approval A successful review ends in an approval order, often carrying conditions such as post-approval surveillance studies.4U.S. Food and Drug Administration. PMA Review Process
Approval is an affirmative determination based on the device’s own merits. The FDA is not saying “close enough to something we already accepted.” It is saying “we looked at the trial data and concluded this device is safe and effective.”
Why the Distinction Matters
The two words carry different legal weight, and using them interchangeably, as some marketing materials do, misrepresents what the FDA actually evaluated.
For everyday devices, the distinction is often academic. A bandage or a tongue depressor does not need original clinical trials, and no one is worse off because it reached the market through general controls rather than a PMA. The distinction becomes practical in high-stakes decisions. When a patient is weighing an implantable cardiac device or an artificial joint, knowing whether the FDA approved the product based on clinical trial data or cleared it based on similarity to an older product provides useful context about what the agency actually verified.
Neither status is inherently better. A well-established Class II device with decades of cleared iterations may have a stronger real-world safety record than a newly approved Class III device that has only just finished its pivotal trial. The nature of the FDA’s review is simply different, and patients and clinicians benefit from knowing which standard was applied.
How Device Risk Class Decides Which Word Applies
Whether a device is cleared or approved is not something the manufacturer chooses. It follows almost entirely from the FDA’s risk classification, which sorts roughly 1,700 device types into three classes.5U.S. Food and Drug Administration. Classify Your Medical Device
Class I covers the lowest-risk devices, such as bandages, tongue depressors, and handheld surgical instruments. About 74% of these are exempt from any premarket notification at all. The manufacturer registers its establishment, lists the device, and follows general controls like proper labeling and good manufacturing practices.5U.S. Food and Drug Administration. Classify Your Medical Device These devices are neither cleared nor approved in the strict sense; they are simply lawfully marketed under general controls.
Class II covers moderate-risk devices subject to special controls on top of the general ones, often including performance standards, post-market surveillance, or patient registries. Most reach the market through 510(k) clearance. When you hear “FDA-cleared,” this is almost always the category.
Class III covers the highest-risk devices, typically those that sustain life, support vital body functions, or are permanently implanted. These go through PMA and, if successful, come out approved.2U.S. Food and Drug Administration. Premarket Approval (PMA)
The same framework applies to standalone software designed for a medical purpose. Software that diagnoses conditions, recommends treatments, or analyzes medical images is a regulated medical device in its own right and follows the same risk-based pathway as hardware.6U.S. Food and Drug Administration. Software as a Medical Device (SaMD)
Other Words You Will See
Cleared and approved are not the only labels the FDA uses, and a few adjacent terms get mistaken for one or the other.
Granted (De Novo classification). When a manufacturer develops a genuinely novel device with no predicate but only low-to-moderate risk, it can request De Novo classification instead of going through the full PMA burden. A successful De Novo request results in the FDA classifying the device into Class I or Class II and creating a new regulatory classification that future devices can use as a predicate.7U.S. Food and Drug Administration. De Novo Classification Request A De Novo grant is closer to clearance than approval in what the FDA actually reviewed. It is not a PMA approval.
Designated (Breakthrough Devices). Breakthrough Device designation is a program status, not a marketing authorization. Devices that treat life-threatening conditions and represent a significant advance can qualify for prioritized review and interactive feedback from FDA staff during development.8U.S. Food and Drug Administration. Breakthrough Devices Program The device still needs clearance, De Novo grant, or approval before it can be sold. A “Breakthrough” tag by itself does not authorize marketing.
Authorized under Humanitarian Device Exemption (HDE). Some devices treat conditions so rare that a full clinical trial is statistically impractical. The HDE pathway applies to devices intended for conditions affecting no more than 8,000 individuals in the United States per year, and requires the manufacturer to demonstrate probable benefit rather than the rigorous effectiveness data a PMA demands.9eCFR. 21 CFR Part 814 Subpart H – Humanitarian Use Devices An HDE is a distinct authorization, not a standard PMA approval.
What Both Statuses Require After Market Entry
Whether a device was cleared or approved, reaching the market is not the end of the manufacturer’s obligations. The FDA imposes ongoing duties that apply to both.
Manufacturers must report to the FDA when they learn that one of their devices may have caused or contributed to a death or serious injury, within 30 calendar days of becoming aware. If the event requires immediate action to prevent a serious public health risk, the deadline shrinks to five business days. Malfunctions that could plausibly cause death or serious injury if they recurred must also be reported on the 30-day timeline, even if no one was actually harmed.10eCFR. 21 CFR Part 803 – Medical Device Reporting
Most devices must also carry a Unique Device Identifier in both human-readable text and a machine-readable format like a barcode. The identifier includes a device identifier segment, and where the label carries a lot number, serial number, manufacturing date, or expiration date, those are embedded as a production identifier. Class I devices are not required to include the production identifier portion.11eCFR. 21 CFR Part 801 Subpart B – Labeling Requirements for Unique Device Identification
When a distributed device is defective or violates FDA requirements, the manufacturer is expected to notify the appropriate FDA district office immediately and begin a recall. The manufacturer identifies the affected product, explains the hazard, estimates how much product is in distribution, and communicates instructions to anyone in the supply chain who may have the device.12eCFR. 21 CFR Part 7 Subpart C – Recalls (Including Product Corrections) The FDA assigns a recall classification reflecting the severity of the hazard, with Class I recalls representing the most serious risk.
Approved devices frequently carry extra conditions beyond the standard duties. The FDA can require continuing evaluation and periodic reporting on a PMA device’s safety, effectiveness, and reliability, including specifying the number of patients to be monitored and the reports the manufacturer must submit.13eCFR. 21 CFR 814.82 – Postapproval Requirements Failing to comply with those post-approval conditions is grounds for the FDA to withdraw the approval entirely.
So the labels differ in what the FDA verified up front, but not in whether the agency keeps watching. Once a device is on the market, cleared and approved products alike stay under the FDA’s post-market rules for as long as they are sold.