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VALID Act of 2021
12/31/2022, 4:59 AM
Summary of Bill HR 4128
The main goal of the VALID Act is to establish a framework for the regulation of IVCTs to ensure their accuracy and reliability. The bill aims to streamline the approval process for these tests, while also ensuring that they meet high standards for accuracy and effectiveness.
One key aspect of the VALID Act is the establishment of a new regulatory pathway for IVCTs, separate from the existing framework for medical devices. This new pathway would allow for more efficient approval of these tests, while still maintaining rigorous standards for their performance. Additionally, the VALID Act includes provisions for increased transparency and oversight of IVCTs, including requirements for manufacturers to provide data on the performance of their tests and to report any adverse events that may occur. Overall, the VALID Act of 2021 seeks to modernize the regulation of IVCTs in the United States, with the goal of ensuring that these tests are accurate, reliable, and safe for patients. The bill is currently being debated in Congress, with stakeholders from the medical device industry, healthcare providers, and patient advocacy groups all weighing in on its potential impact.
Congressional Summary of HR 4128
Verifying Accurate Leading-edge IVCT Development Act of 2021 or the VALID Act of 2021
This bill requires the Food and Drug Administration (FDA) to regulate in vitro clinical tests (IVCTs).
Currently, the FDA and the Centers for Medicare & Medicaid Services have authority to regulate in vitro diagnostic devices. The bill defines IVCTs, which includes in vitro diagnostic devices, as tests intended for the collection, preparation, analysis, or in vitro clinical examination of specimens from the human body to provide information about a disease, condition, or treatment.
An IVCT may not be introduced into interstate commerce unless it has received FDA premarket approval or is covered by certain exemptions, such as an exemption for a test that (1) was developed and introduced before this bill's enactment and meets certain requirements, (2) is a low-risk test, (3) is solely for public health surveillance, (4) is covered by a technology certification issued under this bill, or (5) has received a humanitarian exemption or emergency use authorization.
The FDA may grant upon application a technology certification. Generally, such a certification covers a group of tests that use a single technology and may be evaluated using a representative test. While such a certification is valid, a qualifying IVCT that falls within the scope of the certification shall be cleared for interstate commerce.
The bill also imposes various requirements related to IVCTs, including those related to quality control, labeling, and reporting adverse events.
The FDA shall have various enforcement authority, including authority to order the recall of an IVCT with a reasonable probability of causing serious adverse health consequences.
