Does Your SaMD Need a 510(k)? Or Is De Novo or PMA the Real Path?

TL;DR: Most Software as a Medical Device (SaMD) products in the U.S. go through the 510(k) pathway.

But if your software has no predicate or treats a critical condition, the FDA may require a De Novo or PMA submission. Here’s how to tell:

Pathway	When It Applies	Typical Risk
510(k)	Predicate exists and risk is low-to-moderate (FDA Class II or Class I “reserved”)	IMDRF II–III
De Novo	No predicate and overall risk is low-to-moderate (cannot be Class III)	IMDRF II–III
PMA	High-risk / critical care software (life-supporting, life-sustaining, or high-impact diagnostic)	IMDRF IV

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Why Choosing the Right SaMD FDA Pathway Matters

If you pick the wrong FDA submission route, the cost isn’t just money—it’s 8–12 months of delay, team fatigue, and missed revenue.

Each pathway:

• Has different timelines

• Requires different supporting evidence

• Triggers different regulatory expectations

  
  

So how do you know which one fits your SaMD?

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When 510(k) Is the Right Path

510(k) is the most common FDA submission type—and for many SaMDs, it’s exactly what you need.

✅ You qualify if:

• There’s an existing predicate device with the same intended use

• Your software presents moderate risk

• You can demonstrate substantial equivalence

  
  

👉 Examples:

• AI for diabetic retinopathy screening (predicate: IDx-DR)

• Cardiac rhythm classifiers

• Decision support software for non-critical conditions

  
  

Bonus: many SaMD submitters now use the FDA’s eSTAR template, which can speed up review and improve formatting compliance.

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When De Novo Applies Instead

If your software is moderate risk but has a, you’re in De Novo territory.

Key signs you need De Novo:

• You can’t find a similar 510(k) cleared product

• You’re targeting a novel application

• Your risk level is acceptable, but your innovation is first-of-its-kind

  
  

👉 Example: IDx-DR — De Novo # DEN180001: autonomous AI software that analyzes retinal fundus images to flag adults with diabetes who have more-than-mild diabetic retinopathy for specialist referral. No predicate existed—De Novo approved.

🧠 Note: Once a De Novo is granted, future similar products can then use it as a predicate

for their own 510(k).

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When PMA Is Required

If your software:

• Directly manages or treats a critical condition

• Impacts survival or high-risk therapeutic outcomes

• Or involves life-sustaining decisions without human review

👉 You likely need a Premarket Approval (PMA).

PMA is:

• The most burdensome route

• Requires clinical trials, human factors testing, and robust validation

• Can take 12–24+ months

  
  

👉 Example: SecondLook Computer-Aided Detection System — PMA # P010038: image-analysis software that flags suspicious regions on digital mammograms so radiologists can catch potential breast-cancer lesions that might be missed on first read.

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Time & Cost Comparison Table

Pathway	Avg. Review Time	FDA Fee (2025)	Notes
510(k)	90–150 days	$24,335 ($6,084 small biz)	eSTAR encouraged
De Novo	150–270 days	$162,235 ($40,559 small biz)	No predicate needed
PMA	12–24 months	$540,783 ($135,196 small biz)	Requires clinical trials

⚠️ Costs don’t include consultant or testing fees.

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FAQs

Q: Can I convert a De Novo into a 510(k)?

Not exactly. But once a De Novo is granted, it becomes a predicate that others can reference in their 510(k) submissions.

Q: What if I upgrade the algorithm after clearance?

You may need a new 510(k) or submit a Predetermined Change Control Plan (PCCP) in advance. FDA wants predictability.

Q: Does EU MDR classification affect my FDA pathway?

Not directly—but if your software is Class IIb or III in Europe, it may signal De Novo or PMA needs in the U.S.