For FDA's fiscal year 2027, which started on 1 October 2026, the standard user fee for an original PMA is USD 636,732 and for a 510(k) USD 28,653 (Federal Register). The fee is the smallest part of the difference.
The two routes answer different legal questions. A 510(k) asks whether the device is substantially equivalent to a legally marketed predicate. A PMA asks whether valid scientific evidence gives reasonable assurance that the device is safe and effective. This article compares the two on legal basis, evidence, review, fees and changes after market entry.
The two routes side by side
| 510(k) | PMA | |
|---|---|---|
| Legal basis | FD&C Act section 510(k); 21 CFR 807 Subpart E | FD&C Act section 515; 21 CFR Part 814 |
| Question | Is the device substantially equivalent to a legally marketed predicate? | Does valid scientific evidence give reasonable assurance of safety and effectiveness? |
| Typical class | Class II, some Class I, and certain preamendment Class III devices for which FDA has not yet required a PMA | Class III |
| Evidence | Comparison with the predicate, supported by performance testing and, where needed, clinical data | Nonclinical and clinical studies, manufacturing information and labelling (21 CFR 814.20) |
| Outcome | Clearance | Approval |
| Changes after market entry | New 510(k) when a change could significantly affect safety or effectiveness, or changes the intended use | PMA supplement for changes affecting safety or effectiveness (21 CFR 814.39) |
Sources: FDA, Premarket Notification 510(k); Premarket Approval.
Which route applies
The route follows the device type, not the manufacturer's preference. The classification regulation and product code show whether a device needs a 510(k), a PMA, or neither. Our guide to the FDA device classification database explains how to find them, and our article on medical device classification at FDA covers the controls behind each class.
Two special cases:
Preamendment Class III devices: some still go through a 510(k) until FDA publishes a regulation requiring a PMA. Our article on Class 3 medical devices explains this.
No predicate: a new device type is automatically Class III. If general controls, or general and special controls, can provide reasonable assurance of safety and effectiveness, a De Novo request can classify it into Class I or II instead of requiring a PMA.
What a 510(k) has to show
Substantial equivalence means the device has the same intended use as the predicate and either:
the same technological characteristics; or
different technological characteristics that do not raise different questions of safety and effectiveness, with performance data showing it is as safe and effective.
Most 510(k)s rely on bench testing, software verification and validation, and other performance data rather than clinical studies. In our view, for software the comparison should cover intended use, inputs, outputs, clinical claims, algorithm and cybersecurity characteristics, and validation results, side by side with the predicate.
What a PMA has to show
A PMA stands on its own evidence. Under 21 CFR 814.20, the application includes, among other things, a device description, manufacturing information, nonclinical laboratory studies, clinical investigations, a bibliography and proposed labelling.
Where a clinical investigation needs FDA approval before it starts, an investigational device exemption comes first. In our view, the PMA evidence plan, including endpoints and the IDE, should be fixed before the clinical programme begins.
Review and inspection
| 510(k) | PMA | |
|---|---|---|
| FDA review | MDUFA goal of 90 FDA days. The clock stops while FDA waits for answers to additional information requests | Filing decision, then a review period set in statute of 180 days, which can be extended by a major amendment |
| Inspection | Not typically before clearance | Usually a pre-approval inspection of manufacturing against the QMSR |
| Advisory panel | Rarely | Possible, especially for first-of-a-kind devices |
Sources: FDA, 510(k) and PMA review process pages.
FDA review days are not calendar days. In our view, plan on elapsed time, including the time needed to answer FDA's questions and, for a PMA, clinical study and inspection readiness.
Fees for fiscal year 2027
| Submission | Standard fee (USD) | Small business fee (USD) |
|---|---|---|
| PMA | 636,732 | 159,183 |
| Panel-track supplement | 509,386 | 127,347 |
| De Novo request | 191,020 | 47,755 |
| 180-day supplement | 95,510 | 23,878 |
| Real-time supplement | 44,571 | 11,143 |
| 510(k) | 28,653 | 7,163 |
| 30-day notice | 10,188 | 5,094 |
| Annual fee for periodic reporting on a Class III device | 22,286 | 5,572 |
| Annual establishment registration | 13,785 | 13,785 |
Source: FDA, MDUFA user fee rates for fiscal year 2027.
For a PMA device, supplements and annual reports add recurring fees. Clinical studies, software validation and manufacturing controls usually cost far more than the fees.
Changes after market entry
510(k): a change that could significantly affect safety or effectiveness, or a major change to intended use, needs a new 510(k). FDA's guidance on software changes helps decide this for software.
PMA: a change affecting safety or effectiveness generally needs a PMA supplement before it is implemented. The type depends on the change: a panel-track supplement for significant changes needing substantial clinical data, a 180-day supplement for other significant changes, a real-time supplement for minor changes, and a 30-day notice for certain manufacturing changes. Approved PMAs also need annual reports under 21 CFR 814.84.
In our view, the change model should be part of the pathway decision. For software that is updated often, the PMA supplement process has a large effect on release planning. Our article on IEC 62304 covers the software change process behind these decisions.
A hypothetical example
Hypothetical example: a Dutch SaMD company has two products.
Product A fits a Class II product code with cleared predicates that have the same intended use. It prepares a 510(k) built on a predicate comparison and software validation, and plans each algorithm update against FDA's software change guidance.
Product B fits a Class III product code that requires a PMA. It plans a clinical study under an IDE, prepares for a manufacturing inspection, and budgets for supplements and annual reports.
The same engineering team can work on both, but the regulatory cost of each software change will be very different.
Conclusion
A 510(k) is a comparison; a PMA is a full demonstration of safety and effectiveness. The device type decides which applies, and that choice shapes the evidence, the review, the fees and how every later change is handled.
In our view, confirm the product code and classification first, then build the evidence plan and the change model around the route that applies.
If you need help choosing and planning your US route, our regulatory strategy team can help, or contact MedQAIR.
Frequently asked questions
What is the main difference between a 510(k) and a PMA?
A 510(k) shows substantial equivalence to a legally marketed predicate. A PMA shows, with its own valid scientific evidence, reasonable assurance of safety and effectiveness.
Can a Class III device use a 510(k)?
Some can. Certain preamendment Class III device types go through a 510(k) until FDA publishes a regulation requiring a PMA.
How long does FDA take to review a 510(k)?
FDA's MDUFA goal is a decision within 90 FDA days. The clock stops while FDA waits for answers to its questions, so elapsed time is usually longer.
How much does a PMA cost in FDA fees?
For fiscal year 2027, USD 636,732 standard or USD 159,183 for a qualifying small business, plus fees for supplements and annual periodic reporting.
What if there is no predicate for my device?
The device is automatically Class III. If its risks can be controlled with general and special controls, a De Novo request can classify it into Class I or II.
