BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
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We complete your 510(k) review in ≤65 days
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Our experience in all in-vitro diagnostic (IVD) scientific, pre-analytical, analytical, biological, and clinical aspects enable us to fully understand and guide you through the 510(k) review process.  

Efficiency

Save up to 65% of the FDA review time (65 vs 203 days on average). See the Review Process

Flexibility

Accommodate your deadlines and streamline the workflow accordingly

Competitive Cost

One simple fee to conduct the review and communicate with the FDA on your behalf- No FDA User Fee or surprise costs

Exceptional Quality of Service

Dedicated to delivering excellent customer service and creating open and honest relationships with our clients

Transparency and Dedication

Encourage and appreciate client feedback; committed to addressing any concerns to our clients' satisfaction

Streamlined Communication

Promote direct client interaction with your designated reviewer

Our Accreditation for 510(k) Review

We are fully accredited by the Center for Devices and Radiological Health (CDRH) as a Third Party Reviewer. This program gives manufacturers of certain devices the opportunity to submit their 510(k) to private parties (Recognized Third Parties) identified by the FDA for review instead of submitting directly to CDRH. The purpose of the program is to improve the efficiency and timeliness of the 510(k) process.
We are accredited to review Class I and Class II IVD devices for Clinical Chemistry, Hematology, Immunology, Microbiology, Pathology, and Toxicology.

For details on our accreditation, access the FDA website

What is a 510(k)?

A 510(k) is the technical submission required by the United States Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. A 510(k) details technical, safety, and performance information about a medical device. The FDA must approve your device before you can legally sell or distribute it in the US.

A 510(k) is a premarket submission made to the FDA to demonstrate that a given device is at least as safe and effective (i.e., substantially equivalent) to a legally marketed device that is not subject to PMA (Premarket Application). Submitters must compare their device to one or more similar and legally marketed devices, commonly known as the "Predicate”, and make and support their substantial equivalence claims.

​For more information, click here to review FDA guidance
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  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us