Legislators Release New Draft Bill Incorporating FDA Ideas for Diagnostics Regulation

The FDA’s version of the bill includes proposals related to premarket approval, provisional approval, and a precertification program, and makes explicit its authority to revoke approval, request raw data, and take corrective action against test developers in order to protect the public health. Anticipating the release of the VALID Act, FDA Commissioner Scott Gottlieb last week issued a definitive public statement on the agency’s position on reforming the regulatory framework for diagnostics. 

“The draft legislation would establish a risk-based approach to IVCT regulation, prioritizing FDA resources for the highest-risk tests that expose patients to serious or irreversible harm. The legislation also would establish a precertification program for lower-risk tests that are not otherwise required to go through premarket review … High-risk tests, such as novel tests, would be required to undergo premarket review to verify analytical and clinical validity. FDA could require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency.”

Source: https://www.genomeweb.com/molecular-diagnostics/legislators-release-new-draft-bill-incorporating-fda-ideas-diagnostics