FDA 510 (k) certification? An example to help you understand the key process!

What is 510 (k) certification?

FDA 510 (k) is the market access approval process for medical devices by the US Food and Drug Administration (FDA), requiring companies to demonstrate that their new products are "substantially equivalent" in safety and efficacy to predicate devices that have already been legally marketed.

Real case analysis: Certification process of blood glucose monitoring device

Let's learn step by step about the 510 (k) process through a certification case of a new non-invasive blood glucose monitor:




Step 1: Determine product classification (takes 1-2 weeks)

Case: Our blood glucose meter belongs to Class II medical devices, with product code "NBW", and requires submission of a 510 (k) application.




Key points:

Confirm product category through FDA classification database

Clarify whether clinical data is needed (not required in this case)




Step 2: Find predicate devices (takes 2-4 weeks)

Case: Dexcom G6, which has already been launched, was chosen as the main predicate device because its technical characteristics are similar to our product.




Key points:

Select 1-3 most similar legally listed devices

Record the 510 (k) number and key parameters of the predicate device




Step 3: Prepare technical documentation (takes 8-12 weeks)

The case document includes:

Performance test data: Accuracy reaches 98.5% (equivalent to 98.2% of Dexcom G6)

Biocompatibility report: tested according to ISO 10993-1

Electromagnetic compatibility test: compliant with IEC 60601-1-2 standard

Software validation: Following IEC 62304 standard




Key points:

All tests must be conducted by an ISO 13485 certified laboratory

The data must display substantial equivalence with the predicate device




Step 4: Submit a 510 (k) application (FDA review for 90 days)

Case submission content:

Application Form (FDA 3601)

Summary statement

Declaration of Authenticity and Accuracy

Device description

Substantial equivalence argument

performance data

Label Sample

Sterilization information (if applicable)




Key points:

Electronic submission through FDA ESG system

The application fee for 2023 is $19870 ($4967 for small businesses)




Step 5: FDA Review and Response

Case timeline:

Day 30: FDA confirms receipt of application

Day 60: FDA raises supplementary questions about calibration algorithms

Day 75: Submit supplementary data

Day 88: Obtain a "substantial equivalence" decision letter




Key points:

The average review time is about 90 days, and complex products may be delayed

About 30% of applications will receive additional information requests from the FDA




Key factors for success

Predicate device selection: Select the marketed device with the closest technical parameters

Test design: Ensure that the test plan can fully demonstrate substantive equivalence

Document integrity: Avoiding review delays caused by incomplete information

Preliminary communication: It is recommended to submit a Pre Sub application for complex products to obtain FDA feedback

Common Error Warning

Selecting inappropriate predicate devices

The test data is insufficient or does not meet the standards

X does not include all necessary parts

Underestimating document preparation time

Through this real-life case, it can be seen that the core of 510 (k) certification lies in "proving similarity" rather than "proving innovation". Reasonable planning and sufficient preparation can usually complete the entire process within 4-6 months.