COLA’s reviews are quick and affordable. Contact us to find out more.
Faster Review • Faster Clearance • Faster Product Launch
Faster Review • Faster Clearance Faster • Product Launch
COLA is committed to work with you to get your device reviewed and to the FDA for final determination as quickly as possible.
Why COLA?
We are ISO 9001:2015 certified, which means our quality engineered processes are driven by standardization and customer satisfaction. Our focus is to expedite your 510(k) application to the Food and Drug Administration (FDA) approval and get you to the market faster. With 30 years of experience promoting excellence in laboratory medicine and patient care, our experienced staff can conduct a thorough and swift review.
FDA 510(k) review is required for a medical device to be marketed in the United States. Third Party Review is an alternative that can be faster than a traditional FDA 510(k) review. COLA’s team of scientific experts, regulatory leaders and workflow professionals provide thorough and accelerated review of 510(k) applications. Companies that use Third Party Review are exempt from paying the FDA’s Medical Device User Fees and instead pay a fee to COLA for the review.
How we help your device get to market faster.
Step 1
COLA confirms your eligibility for the program.
Step 2
Fill out a detailed application showing the device is “substantially equivalent” to a device already on the market.
Step 3
COLA’s staff reviews the application and ensures it is accurate and has all of the correct information.
Step 4
COLA staff makes a recommendation if the device is “substantially equivalent” to an already marketed device.
Step 5
The recommendation is sent to the FDA who has 30 days to make a determination.
Step 6
Once the FDA concurs then you are able to market your product in the US.
Step 1
COLA confirms your eligibility for the program.
Step 2
Fill out a detailed application showing the device is “substantially equivalent” to a device already on the market.
Step 3
COLA’s staff reviews the application and ensures it is accurate and has all of the correct information.
Step 4
COLA staff makes a recommendation if the device is “substantially equivalent” to an already marketed device.
Step 5
The recommendation is sent to the FDA who has 30 days to make a determination.
Step 6
Once the FDA concurs then you are able to market your product in the US.
We are authorized to review:
Clinical Chemistry
- 862.1155 Human chorionic gonadotropin (HCG) test system.
- 862.1345 Glucose test system
- 862.1825 Vitamin D test system
Microbiology
- 866.1620 Antimicrobial susceptibility test disc
- 866.2390 Transport culture medium
- 866.2560 Microbial growth monitor
- 866.2900 Microbiological specimen collection and transport device
- 866.3390 Neisseria spp. direct serological test reagents
Have questions?
Email the Third Party Review program at ThirdParty@cola.org or call (800)-981-9883 and ask for the Third Party Review Group.
Phone: (800) 981-9883 | Email: ThirdParty@cola.org
Fees & Application
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