Expanding into the U.S. market is a milestone for many MedTech innovators, but it brings with it a complex regulatory challenge. For most medical devices, the most practical route to U.S. market entry is the FDA 510(k) submission a pathway that relies on demonstrating substantial equivalence to an existing, legally marketed predicate device.
Selecting the right predicate can dramatically influence your submission timeline, testing requirements, and chances of clearance. Choosing poorly can lead to delays, rejections, or even a complete restart of the process.
Understanding the 510(k) Pathway
The FDA offers several routes to market, including Premarket Approval (PMA), De Novo classification, 513(g) requests, and 510(k) submissions.
The 510(k) pathway is by far the most common. It’s designed for devices that are substantially equivalent to an existing legally marketed product.
Why most companies choose 510(k):
- Lower cost compared to PMA.
- Faster review and clearance.
- Leverages an existing device’s regulatory history.
- Reduces the overall evidence burden if equivalence can be demonstrated.
More than 85% of medical devices cleared for the U.S. market follow this route.
What Is a Predicate Device?
A predicate device is a legally marketed product to which your new device is compared.
To qualify as a valid predicate, it must:
- Have the same intended use as your device.
- Have similar technological characteristics, or any differences must not raise new safety or effectiveness questions.
- Be legally marketed in the U.S. (i.e. cleared through 510(k), exempt, or pre-amendment).
What makes a good predicate:
- Similar intended use and technology.
- Clear FDA clearance status.
- Established safety and performance profile.
- Publicly available 510(k) summary for reference.
Why Predicate Selection Matters
Predicate choice sets the tone for the entire submission. It defines what the FDA will expect in terms of testing, data, and documentation.
A well-chosen predicate can streamline your route to market. A poor choice can lead to:
- Additional testing (e.g. biocompatibility, usability, or clinical studies).
- Prolonged review cycles or requests for additional information.
- Rejection or reclassification under PMA or De Novo.
Step-by-Step: How to Find the Right Predicate
Step 1: Define Your Device Profile
Start with a clear and detailed description of your device:
- Intended use and indications for use.
- Key technological characteristics.
- Functional principles and materials.
Example: A skin-adhered patch sensor designed for continuous glucose monitoring, transmitting data to a smartphone app for diabetes management.
Step 2: Search the FDA Product Classification Database
Use the FDA Product Classification Database to identify applicable regulation numbers and product codes.
You can search by:
- Keyword (e.g. “continuous glucose monitor”)
- Regulation number
- Product code
This identifies the device class, regulation name, and the associated review panel.
Step 3: Explore the FDA 510(k) Database
Next, search the FDA 510(k) Premarket Notification Database using the product code(s) identified.
You can filter results by:
- Decision date
- Applicant name
- Device name
Export your results into a spreadsheet to compare potential predicates by manufacturer, technology, and clearance history.
Step 4: Deep Dive into Candidate Predicates
For each potential predicate:
- Review the Indications for Use statement.
- Examine the technological description.
- Compare your device’s materials, function, and output.
- Identify any differences that might raise new safety or performance concerns.
If differences exist, anticipate and plan additional testing such as:
- Bench or performance testing.
- Usability evaluations.
- Biocompatibility or software validation studies.
Step 5: Selecting the Best Predicate
Select one or more predicate devices that most closely match your product.
You may use multiple predicates if your device combines technologies or intended uses. In this case:
- Define a primary predicate (closest match).
- Clearly justify any secondary predicates.
- Document how all predicates collectively establish equivalence.
Common Mistakes to Avoid
- Using a predicate that’s too old.
Older devices may be retired, noncompliant, or based on outdated standards. - Confusing marketing claims with indications for use.
The FDA focuses on the intended purpose, not promotional language. - Ignoring technological differences.
Even small variations in materials, algorithms, or energy sources can trigger requests for new data. - Attempting “split predicates.”
Combining different intended uses or technologies from multiple devices can invalidate the comparison.
Summary: Your Predicate Search Workflow
- Define your device’s intended use and technology.
- Search the FDA Product Classification Database.
- Identify relevant product codes.
- Search the FDA 510(k) Database for similar devices.
- Review and compare 510(k) summaries.
- Select and justify your predicate(s) in your submission documentation.
Call to Action
LFH supports MedTech innovators in developing comprehensive U.S. regulatory strategies, including FDA 510(k) submissions, predicate identification, and substantial equivalence assessments. Our consultants help you navigate FDA databases, select the right pathway, and prepare submission-ready documentation that accelerates your route to market.
FAQs
What is “substantial equivalence”?
It means your device is as safe and effective as a legally marketed predicate with the same intended use and similar technology.
Can I use more than one predicate device?
Yes. Multiple predicates are permitted if they collectively support your claims, but you must clearly justify their relevance.
How do I know if my device requires De Novo or PMA instead?
If no valid predicate exists, or your technology is novel and introduces new risks, the FDA may require a De Novo or PMA submission.
How long does a 510(k) submission take?
Typically 3–6 months, depending on FDA workload, predicate suitability, and data completeness.
