Challenge: A subsidiary of a global molecular diagnostics company needed assistance developing an effective regulatory strategy for a drug-of-abuse assay.

Beaufort Solution: In-house clinical trial plans and previous 510(k) submissions had been rejected by the FDA.  The company engaged Beaufort to redefine the intended use of the assay and provide guidance regarding effective interactions with FDA.  Beaufort redefined the intended use to specify the results of the product and to enable FDA to focus on the potential positive uses of the product.  After previous applications, literature, and data were reviewed, Beaufort redesigned a clinical trial protocol that would support the new intended use of the assay, providing appropriate focus on the actual functionality of the product.  This done, the client was positioned to move forward in their plans for the product.

Date posted: October 27, 2011

Categories: Case Studies Regulatory Affairs