How Medical Devices Are Approved: FDA Clears vs Approves
Medical devices often carry labels that say “FDA cleared” or “FDA approved,” and the wording can create confusion because the terms sound similar. This article explains How Medical Devices Are Approved in the United States and why the FDA uses more than one pathway to review devices. Many moderate-risk devices go through 510(k) and earn “FDA cleared” status, while many higher-risk devices go through PMA and earn “FDA approved” status. Each pathway asks different questions and uses a different evidence standard.
FDA oversight and device risk levels
The FDA oversees medical devices through the Center for Devices and Radiological Health (CDRH), which manages much of the premarket review and post-market oversight for devices. CDRH reviews many devices before sale, and it also tracks safety signals after launch through reporting systems and other monitoring tools.
FDA CDRH
Federal law defines a medical device as a tool, machine, implant, test reagent, or similar product used to diagnose, treat, or prevent disease, or to affect the body’s structure or function. Devices do not work mainly through chemical action or metabolism, which helps separate devices from many drugs and biologics in the legal framework.
FDA Overview
CDRH looks for “valid scientific evidence,” and the FDA connects that evidence to risk and intended use. A simple, low-risk device may need limited testing, while a higher-risk device may require a wider set of studies and stronger supporting data.
Common evidence types include:
- Bench tests: strength, accuracy, wear, durability
- Biocompatibility: how materials interact with the body
- Sterilization validation: proof a sterile device stays sterile
- Software V&V: proof software performs as designed
- Human factors: proof people can use it safely
Some devices also need clinical data, especially when the device risk increases or when bench tests alone cannot answer key safety and performance questions.
Risk classes that shape the pathway
The FDA sorts devices into classes based on risk, and that class often determines the most likely regulatory pathway.
FDA Classify
- Class I (low risk): The FDA relies mainly on general controls, and many devices qualify for exemption from premarket submission. Many basic, non-powered instruments fall into Class I.
- Class II (moderate risk): The FDA often adds special controls such as test methods, performance standards, and labeling rules. Many powered devices and many diagnostic tools land here, and many Class II devices use 510(k).
- Class III (high risk): Many implanted devices that support or sustain life land here. These devices often require PMA because the FDA needs stronger, more direct evidence of safety and effectiveness.
Manufacturers often confirm classification with FDA tools, especially when product codes and controls determine what a submission must include.
FDA Market Guide
FDA Class DB
“FDA cleared”: the 510(k) pathway
Many devices reach the market through 510(k), which focuses on comparison to an existing legally marketed device. A company submits a 510(k) premarket notification to the FDA and compares the new device to a predicate device already on the market, using the FDA’s standard of substantial equivalence.
FDA 510(k)
A 510(k) review often looks like a structured argument. The submission explains the intended use, compares key features, and shows that performance and risk align with what the predicate already established.
What counts as a predicate device
A predicate device must have “legally marketed” status. The FDA may recognize a predicate based on prior clearance, approval, or other lawful marketing routes, depending on the device history and classification. The 510(k) submission links the new device to that predicate and explains why the comparison makes sense.
What “substantial equivalence” means in plain terms
The FDA asks a focused question: does the new device match the predicate’s intended use and key performance? The FDA also checks differences in technology, because some differences can raise new questions of safety or effectiveness. A major design change can trigger those new questions, which can block a finding of substantial equivalence.
FDA explains the framework in its substantial equivalence guidance.
FDA 510(k) Guide
What a 510(k) submission often includes
A 510(k) submission often includes:
- A device description
- Intended use and indications
- Risk analysis and risk controls
- Bench testing results
- Software and cybersecurity information when needed
- Biocompatibility and sterilization details when needed
- Labeling and instructions for use
- A comparison to the predicate device
This list can look long, but most of it supports the same point: the device performs as safely and effectively as the predicate for the cleared use.
What “FDA cleared” means
“FDA cleared” means the FDA accepted substantial equivalence for a specific use, based on the evidence in the 510(k). Clearance does not equal PMA approval, and it also does not prove the device works better than other options in the same category.
Some sources explain the difference in plain language and show why accurate wording matters.
CITI Cleared vs Approved
TFG PMA vs 510(k)
“FDA approved”: the PMA pathway
Some devices carry higher risk, so the FDA applies a more rigorous premarket process. These devices often require Premarket Approval (PMA), which represents the FDA’s strictest device review pathway.
FDA PMA
PMA focuses less on comparison and more on direct proof. A PMA application must support “reasonable assurance” of safety and effectiveness for the intended use, and the FDA often expects clinical evidence for many PMA devices.
What a PMA application often includes
A PMA application often includes:
- Detailed device design information
- Manufacturing and quality system information
- Bench testing and stress testing
- Nonclinical studies and sometimes animal studies
- Human clinical studies that test safety and effectiveness
- Risk–benefit analysis and statistics
- Labeling that matches the evidence
FDA lists common PMA sections and expected content.
FDA PMA Contents
Clinical evidence in plain terms
Clinical studies for PMA devices often measure clear outcomes, and they track both benefits and risks over time. They record safety problems, device failures, and complications, and they also measure whether the device achieves its intended clinical benefit.
Common clinical focus areas include:
- Safety outcomes: adverse events, complications, and serious risks
- Effectiveness outcomes: measures tied to the intended use
- Follow-up time: short-term and long-term results when risk requires it
- Device reliability: breakage, malfunction, or repeat procedures
Cleared vs approved at a glance
“Cleared” and “approved” describe different FDA decisions, and each term matches a different evidence standard. The wording matters because it signals what kind of review supported the decision.
Feature | FDA Cleared (510(k)) | FDA Approved (PMA) |
Typical device class | Many Class II; some Class I | Many Class III |
Core standard | Substantial equivalence | Reasonable assurance of safety and effectiveness |
Typical evidence | Bench testing + focused studies | Broad testing + clinical studies (often) |
Label term | “FDA cleared” | “FDA approved” |
Other FDA terms and how to verify status
People often see other phrases on packaging or websites, and these phrases can look official even when they do not reflect a clearance or approval decision.
“FDA registered” and “FDA listed”
Companies register facilities and list devices with the FDA, but registration and listing do not equal clearance or approval.
FDA Reg/List
“FDA regulated”
The FDA regulates many categories of products, but the phrase “FDA regulated” does not automatically mean premarket review occurred. Clearance and approval refer to specific FDA decisions tied to specific pathways.
FDA Devices Hub
De Novo and “FDA granted”
Some novel, low-to-moderate risk devices go through the De Novo pathway, and the FDA “grants” a De Novo request when it accepts the classification. This pathway differs from 510(k) and PMA, and it often creates a new device type that later devices can reference.
FDA De Novo
How to verify a device’s regulatory status
FDA provides public tools that confirm whether a device has 510(k) clearance or PMA approval, and these tools also show what the FDA reviewed.
- For 510(k) clearance, use the FDA 510(k) database to search by company name, device name, or product code.
FDA 510(k) DB - For PMA approval, use the FDA PMA database to search by applicant, trade name, or PMA number.
FDA PMA DB
FDA also provides a central hub that links to approvals, clearances, and related resources.
FDA Clear/Approve Hub
Clear terms support clear understanding
The FDA regulates medical devices with a risk-based system, and it uses different pathways to match review depth to device risk. Many moderate-risk devices go through 510(k) clearance, while many high-risk devices go through PMA approval. “FDA cleared” and “FDA approved” describe different pathways and different review standards, so accurate wording reduces confusion about what the FDA reviewed and why.
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