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In Vitro Diagnostics

Regulation of in vitro diagnostics and laboratory-developed tests (LDTs) is a nuanced area that continues to evolve. Our multidisciplinary team has many years of experience helping a wide range of companies develop and obtain marketing authorization for IVD tests.  

We work on products regulated by CDRH and CBER, ranging from simple sample preparation and culture media devices to more complex and cutting-edge technologies, such as test systems predictive of drug responses (e.g., companion diagnostics). In parallel to our work in the U.S., we have similar capabilities in Europe through lawyers in our Brussels and other EU offices.



Representative experience

Worked on numerous pre-market submissions for IVDs in the medical device and biologics areas and on Investigational New Drug (IND) applications for various imaging agents.

Extensive experience in negotiating clinical study design and regulatory pathways with the FDA on behalf of our client companies.

We have established regulatory training programs to educate the internal units of major pharmaceutical, biotechnology, and medical device companies regarding QSRs.

We assisted a company in obtaining the first waiver from the FDA under the Clinical Laboratory Improvement Amendments (CLIA) for a syphilis screening test.

Assisted T2 Biosystems, Inc. in preparing a direct de novo product authorization petition for the company’s T2 Candida diagnostic test system.

Assisted with preparing and obtaining FDA approval for the first non-invasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers.

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