FDA Third Party Review

Faster Review • Faster Clearance • Faster Product Launch

Food and Drug Administration (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 Fee Amendments (MDUFA) user fee and instead pay a fee to COLA for the review.

How COLA helps your device get to the market faster.

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    Step 1

    COLA confirms your eligibility for the program.

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    Step 2

    Fill out a detailed application showing the device is “substantially equivalent” to a device already on the market

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    Step 3

    COLA’s staff reviews the application and ensures it is accurate and has all of the correct information

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    Step 4

    COLA staff makes a recommendation if the device is “substantially equivalent” to an already marketed device

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    Step 5

    The recommendation is sent to the FDA who has 30 days to review our finding and concur

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    Step 6

    Once the FDA concurs then you are able to market your product!

COLA is 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
  • 866.3390 Neisseria spp. direct serological test reagents

Why COLA?

COLA is ISO 9001:2015 certified, which means our quality engineered processes are driven by standardization and customer satisfaction.   Our focus is to expedite FDA approval and get you on 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.

COLA is committed to work with you to get your device reviewed and to the FDA for final determination as quickly as possible.

Fees and Application

COLA’s reviews are quick and affordable, less than the FDA’s MDUFA user fee. Contact us to find out more.

Questions?

Email the Third Party Review program at ThirdParty@cola.org or call (800)-981-9883 and ask for the Third Party Review Group.