In advance of a hearing next Thursday, the House Energy & Commerce Committee has released a draft discussion bill that would set up new regulations for in vitro clinical tests.
The 185-page draft bill lays out how it would create a new Center for In Vitro Clinical Tests within the US Food and Drug Administration (FDA). And although the bill refers to the tests as "in vitro clinical tests," it remains to be seen how FDA would regulate the tests differently from in vitro diagnostics (IVDs).
IVDs are tests FDA currently defines as being able to detect diseases, medical conditions or infections and are typically developed by laboratories and IVD companies for use in hospitals and other clinical settings, but can also be developed and marketed directly to consumers.
The bill also comes as FDA in August announced plans via a draft guidance to regulate lab-developed tests more similarly to the way it regulates IVDs. That guidance, if finalized, could place a new burden on industry and academic hospitals that develop such tests.
However, this latest draft bill, which if enacted would presumably work in tandem with the FDA guidance, also notes that these regulations will exclude any test intended by its developer to be for nonclinical uses, such as for forensic testing, drugs-of-abuse testing for employment, insurance and genetic testing for nonclinical purposes.
According to the draft bill, the FDA center (similar to what the FDA draft guidance for lab-developed tests unveiled) will be tasked with classifying in vitro clinical tests as high-risk (if an inaccurate test result would cause serious harm, or death, to the patient), moderate-risk (if an inaccurate
result for the intended use would cause non-life-threatening injury) and low-risk (meaning an inaccurate result would cause minimal or no harm, immediately reversible harm, or no patient disability).
If an in vitro clinical test has multiple intended uses, then the test will be classified based on the intended use of the highest-risk class, according to the draft.
And not later than 90 calendar days after the date of enactment of the bill, FDA would be expected to establish advisory panels to review and consider the classification of each in vitro clinical test. The bill notes that panel members are expected to include physicians, consumers and the in vitro clinical test manufacturing and laboratory industries.
But all classifications made by FDA and the advisory panels can be appealed by industry.
For moderate- and high-risk in vitro clinical tests, the new FDA center will also be tasked with determining whether a test is analytically valid and clinically valid for its intended use based on applications submitted by the manufacturer before it hits the market.
But for the moderate-risk devices, FDA’s burden will be lessened as it will be able to establish by regulation a process under which third parties may review and approve the devices.
There will also be expedited, alternative review pathways by which a manufacturer can submit for approval a test meant for rare diseases, unmet needs or emergency use.
And for low-risk devices, FDA will approve them “so long as the developer of the test submits a notification regarding the test.”
The draft also includes details on premarket requirements for modifications to in vitro clinical tests, the registration of such tests, and other information on the investigational and research use of in vitro clinical tests.
Adverse event reporting requirements and more information on the way industry can appeal a particular classification are also included in the draft.
Text of the Discussion Draft
Notice of the Hearing