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New Framework Suggested

The US Food and Drug Administration's involvement in the Diagnostic Accuracy and Innovation Act goes beyond technical assistance to suggesting a new regulatory framework, writes Jeffrey Gibbs at his FDA Law Blog.

Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) have been shepherding the Diagnostic Accuracy and Innovation Act for regulating diagnostic tests, as GenomeWeb has reported. According to GenomeWeb, FDA provided to Bucshon and DeGette a technical assistance document in which the agency suggested the development of a precertification program for in vitro diagnostics and laboratory-developed tests.

At his blog, Gibbs says FDA offered more than technical comments on the draft bill and instead offered a whole new regulatory framework. It is, he says, a change to how IVDs are regulated. "Rewriting the laws for IVDs is a complicated business, and every word needs to be scrutinized, both for what is intended and for potential unintended consequences," he adds.

Gibbs notes that how new IVDs work with current regulatory framework has become "uneasy" and that there are reasons to argue that how they are regulated should be revised.

Earlier this month, the diagnostic manufacturers group AdvaMedDx said FDA's technical assistance to the draft bill was a "positive step toward enacting legislation modernizing regulation of all diagnostics."