Biology Reference
In-Depth Information
7.3.1 Labeling
The labeling of both the therapeutic and diagnostic are also addressed in the draft guid-
ance. Existing regulations dictate that:
'for drugs and biological products (21 CFR 201.56 and 57), product labeling must include information
about:
1) specific tests necessary for selection or monitoring of patients who need a drug;
2) dosage modifications in special patient populations (e.g., in groups defined by genetic characteris-
tics); and
3) the identity of any laboratory test(s) helpful in following a patient's response or in identifying pos-
sible adverse reactions
[1]
.'
The previously issued regulations also address sections in which to include the appropri-
ate language. The guidance provides clarification in that the novel therapeutic will include
information in its label about the co-developed companion diagnostic device. When appro-
priate, the label should indicate the type of approved or cleared companion IVD companion
diagnostic device, and in cases where the IVD companion diagnostic device is approved after
the therapeutic, the therapeutic label should be updated to reflect the newly approved IVD
companion diagnostic. Regarding device labeling, the guidance reflects that the intended use
of the diagnostic should be included in the labeling for the device. Any subsequently identi-
fied uses, for example in another indication, or for another therapeutic, would require a new
premarket submission to amend the labeling of the diagnostic device to reflect that addi-
tional use.
7.3.2 Investigational Use
While the primary focus of the guidance document is on the filing of and approval for IVD
companion diagnostics in association with a therapeutic, the draft guidance also covers the
use of devices in the scope of clinical trials. As such investigational devices are defined as:
'All diagnostic devices used to make treatment decisions in a clinical trial of a therapeutic product will
be considered investigational devices, unless employed for an intended use for which the device is already
approved or cleared
[1]
.'
In addition to this definition, there is clear language stating that if a device is used to:
'make critical treatment decisions, such as patient selection, treatment assignment, or treatment arm, a
diagnostic device generally will be considered a significant risk device under 21 CFR 812.3(m)(3) because
it presents a potential for serious risk to the health, safety, or welfare of the subject, and the sponsor of the
diagnostic device will be required to comply with the investigational device exemption (IDE) regulations
that address significant risk devices
[1]
.'
This means that the device must follow IDE regulations throughout its use in the clini-
cal trial, and that any combination of a diagnostic and therapeutic trial must comply with
both IDE and Investigational New Drug (IND) regulations. In order to comply with the IDE
regulations, the FDA suggests that information about the planned intended use of the device
Search WWH ::
Custom Search