FDA Cleared vs FDA Approved vs FDA Granted: 2025 Complete Guide
- Beng Ee Lim
- Jul 11
- 7 min read
Updated: Sep 7
In FDA device speak, cleared ≠ approved ≠ granted. Mixing these terms can misbrand your product. FDA cleared means 510(k) approval for Class II devices proven substantially equivalent to predicates. FDA approved refers to PMA approval for Class III high-risk devices after rigorous clinical testing. FDA granted means De Novo authorization for novel low-to-moderate risk devices without predicates that establish new device classifications.
This guide breaks down each term, shows you when to use it in websites, pitch decks, and labeling, and explains how precise language protects your brand with regulators, investors, and sophisticated buyers.
URGENT: Check Your Marketing Materials Right Now
THESE VIOLATIONS COULD DESTROY YOUR COMPANY:
"FDA Registered" implies approval - FDA explicitly states registration "does not denote approval, clearance, or authorization"
Fake FDA certificates - FDA does not issue registration certificates; all such certificates are fraudulent
Wrong pathway claims - Calling a 510(k) device "FDA approved" is misbranding
Logo misuse - Using FDA logo without proper clearance/approval violates federal law
If your marketing materials contain any of these violations, fix them immediately to avoid catastrophic legal consequences.
What FDA Cleared, Approved, and Granted Actually Mean
The Legal Foundation
Firms that misleadingly display certificates alongside information about and photos of a device for sale in the United States to imply review or approval by FDA of the device misbrand the device in violation of the Federal Food, Drug, and Cosmetic Act.
This isn't a minor compliance issue—it's federal law violation with serious consequences.
The Four Critical Pathways
Each term corresponds to specific FDA pathways with distinct legal meanings:
FDA Registered: Company paid fees and listed devices (no safety review)
FDA Cleared: Device proven substantially equivalent via 510(k) (Class II pathway)
FDA Approved: Device demonstrated safety/efficacy via PMA (Class III pathway)
FDA Granted: Novel device authorized via De Novo (new classification pathway)
FDA Registered: The Most Misunderstood Term
What FDA Registration Actually Means:
FDA registration is a mandatory annual requirement for all medical device companies operating in the United States. It simply means your establishment and each of your devices are listed in FDA’s public database so the agency knows where to send inspectors.
Registration ≠ endorsement. “Registration and listing do not denote approval or clearance.”
Registration Requirements
All medical device companies must register annually with FDA regardless of device risk level.
This includes:
Manufacturers
Repackagers
Relabelers
Importers
Critical Understanding: Registration means FDA knows you exist and can inspect you. It implies zero endorsement of your devices.
The Fake Certificate Scam
Third-party “FDA registration certificates”—often bearing the FDA logo—are not issued by FDA. Displaying them, or phrasing marketing copy to suggest FDA endorsement, has led to misbranding warning letters.
Bottom Line: All "FDA registration certificates" are fraudulent. Companies using them face serious legal violations.
Marketing Compliance for Registered Devices
What You CAN Say:
"FDA registered facility"
"Manufactured in FDA registered facility"
What You CANNOT Say:
"FDA approved" (unless actually approved via PMA)
"FDA cleared" (unless actually cleared via 510(k))
"FDA certified" (FDA doesn't certify anything)
FDA Cleared: The 510(k) Pathway
What Does FDA Clearance Mean?
A device is “FDA-cleared” when FDA issues a 510(k) Substantial-Equivalence (SE) letter stating the device is as safe and effective as a legally marketed predicate that is not subject to PMA. 510(k) applies to most Class II devices, many Class I devices that are not exempt, and a limited group of pre-1976 Class III devices awaiting reclassification.
The 510(k) Process
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
Key Point: When the FDA initially categorized devices into classes in 1976, they actually based those categories on an existing list of devices. Their goal was to streamline future device approvals, as companies that could prove substantial equivalence—in other words, that their device was practically the same as an existing, approved device—could secure regulatory approval on that basis without conducting further safety and efficacy trials.
Substantial Equivalence Requirements
To achieve FDA clearance, your device must demonstrate substantial equivalence through one of two paths:
Same Technology, Same Use: The device uses the same technology and will be used for the same purpose as an existing device.
Different Technology, Same Use: The device will be used for the same purpose as an existing device but uses different technology. However, this technology doesn't raise concerns about its safety or effectiveness.
Device Classes That Get Cleared
Class I Devices: Most are exempt from premarket review (bandages, stethoscopes)
Class II Devices: Most require 510(k) clearance (infusion pumps, surgical drills)
FDA Clearance Marketing Rights
What You CAN Say:
"FDA cleared"
"510(k) cleared"
"Cleared for marketing by FDA"
What You CANNOT Say:
"FDA approved" (incorrect pathway terminology)
FDA Approved: The Gold Standard PMA Process
What FDA Approval Means:
FDA approval refers to the process by which a new medical device undergoes rigorous evaluation to ensure its safety and efficacy before it can be marketed in the United States through the Premarket Approval (PMA) process.
PMA Requirements
PMA is FDA's most rigorous regulatory requirement. To gain PMA, manufacturers of Class III devices must provide sufficient scientific evidence that their products are safe and effective.
The PMA process requires:
Comprehensive clinical trials
Rigorous safety and efficacy data
Years of development and testing
Thousands of clinical trial subjects
Class III Device Categories
Life-Supporting Devices: Pacemakers, defibrillators, heart valves
High-Risk Implants: Breast implants, cochlear implants
Critical Diagnostics: Certain imaging systems requiring PMA
The Approval Standard
Class III devices must demonstrate reasonable assurance of safety and effectiveness through valid scientific evidence, not just substantial equivalence to existing devices.
FDA Approval Marketing Rights
What You CAN Say:
"FDA approved"
"PMA approved"
"Approved by FDA for safety and effectiveness"
This is the ONLY pathway that can legally claim "FDA approved."
De Novo: The Fourth Pathway Everyone Forgets
What De Novo Authorization Means
The De Novo pathway provides a route to market for novel devices that don't have predicates but present low to moderate risk. The FDA may review medical devices through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
When Devices Get "Granted"
Devices reviewed through De Novo are "granted" authorization, not cleared or approved. This creates a fourth terminology category many companies miss.
Marketing Rights for De Novo:
"FDA granted"
"De Novo authorized"
"Authorized for marketing by FDA"
The Critical Business Impact of Wrong Terminology
Legal Consequences
Using incorrect FDA terminology constitutes misbranding under federal law, exposing companies to:
FDA enforcement actions
Product seizures
Criminal prosecution
Inspection Failures
If a medical device company can't get basic terminology right, what else might they be getting wrong?
FDA inspectors view terminology errors as indicators of broader compliance problems, leading to:
Enhanced scrutiny during inspections
Additional audit areas
Potential 483 observations
Manufacturing hold recommendations
Market Credibility Loss
Investor Impact: Sophisticated investors recognize terminology errors as red flags indicating regulatory inexperience.
Customer Trust: Healthcare purchasers lose confidence in companies that misunderstand basic FDA requirements.
Competitive Disadvantage: Competitors with proper terminology appear more credible and professional.
Real Cost Calculations
Direct Legal Costs
FDA Enforcement: Legal defense, consultation fees, compliance remediation
Product Recalls: If misbranding leads to safety issues requiring recalls
Lost Sales: Market access suspension during compliance resolution
Indirect Business Impact
Investor Confidence: Terminology errors signal regulatory incompetence to sophisticated investors
Partnership Deals: Healthcare partners avoid companies with compliance red flags
Insurance Premiums: Product liability insurance increases with regulatory violations
Competitive Disadvantage
Companies with proper terminology appear more credible, professional, and regulatory-savvy than competitors making basic mistakes.[
Protect Your Company with Proper FDA Terminology
The Bottom Line: FDA terminology isn't just regulatory compliance—it's business protection. Companies that master these distinctions demonstrate regulatory sophistication while avoiding costly violations.
Remember: In regulated industries, precision matters. The difference between "cleared" and "approved" isn't semantic—it's legal, strategic, and potentially worth millions in avoided violations.
Getting FDA terminology right signals regulatory competence, builds market credibility, and protects your company from devastating compliance failures that destroy businesses overnight.
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Frequently Asked Questions
What does FDA clearance mean?
FDA clearance means your Class II medical device has been reviewed through the 510(k) pathway and deemed substantially equivalent to a legally marketed predicate device. Unlike FDA approval, clearance doesn't require new clinical trials—just proof your device is essentially the same as something already on the market.
Can I say my device is "FDA compliant"?
This generic term doesn't specify the actual regulatory pathway. Better to use specific, accurate terminology like "FDA cleared" or "manufactured in FDA registered facility."
Can I use the FDA logo in my marketing?
No, unless your device is actually cleared or approved. Using the FDA logo without proper authorization violates federal law.
What about international devices sold in the US?
All devices sold in the US must follow US FDA requirements. Foreign approvals don't substitute for proper FDA pathways.
How do I know which terminology applies to my device?
Determine your device classification (Class I, II, or III) and the specific pathway used (registration only, 510(k), PMA, De Novo, EUA).
What happens if FDA finds terminology violations?
FDA can issue warning letters, require labeling changes, seize products, or pursue criminal prosecution for misbranding violations.
Can I fix terminology violations after they're discovered?
Yes, but it's expensive and damaging. Prevention through proper initial terminology is far better than remediation after violations.
Do terminology rules apply to international marketing?
US FDA terminology rules apply to any marketing materials that could reach US audiences, including international websites and trade shows.
