Biology Reference
In-Depth Information
be shared with the appropriate product review center, and also strongly suggests discussing
the IVD companion diagnostic device via pre-IDE submission. It is important to note these
suggested interactions, as these meetings must be appropriately planned for and timed in
accordance with the proposed filing time line for both the therapeutic and the device.
7.3.3 Summary
The regulatory pathway for the IVD companion diagnostic device has historically not
been well defined, and varies widely depending on the governing regulatory author-
ity. Recently, regulatory guidance such as that provided in the Draft Guidance for Industry
and Food and Drug Administration Staff on
In vitro
Companion Diagnostic Devices that we
reviewed here help to clarify this ambiguity
[1]
. However, the guidance provided is only a
draft, is described as representing the current thinking of the FDA, and is not binding. With
this in mind, it is important to have frequent and candid interactions with the regulatory
authority overseeing the device for your region of interest to ensure that opinion and guid-
ance does not change or differ from what has been provided publicly. In addition, each diag-
nostic device has particular technical aspects which may alter the regulatory approach, and
therefore accurate guidance specific to the device should be sought for each new device, ther-
apeutic indication, or device application.
7.3.4 Timing Considerations
As depicted in the previous review of the FDA guidance on
In vitro
Companion Diagnostic
Devices, the FDA strongly suggest a number of different interactions with regulatory author-
ities throughout the assay development and implementation process.
Figure 7.1
is taken from
the draft April 2005 Drug Diagnostic Co-Development Concept Paper
[3]
:
There are two considerations for the proper timing of obtaining CDRH feedback on the
device and therapeutic combination. The first consideration is the appropriate timing to pro-
vide ample data for CDRH to review and provide feedback. In other words, when do we
have enough information to solicit feedback? The second component regards the timing
associated with approval of the diagnostic or gathering feedback appropriate for imple-
mentation in a certain clinical phase. The first consideration is rather straightforward, but
an important distinction. The FDA can provide limited feedback on mere plans, but may be
able to give more insight with data in hand. This consideration is important when planning
for analytical and clinical validation. For example, while validation plans may be reviewed
by the FDA via the pre-IDE, without some data regarding assay qualification and establish-
ment of performance characteristics, the reviewers would have a limited frame of reference
to determine whether validation plans and numbers are sufficient for a particular assay. If
not properly planned for, validation may need to proceed at risk. The second timing con-
sideration is much more complex, as the time lines for approval of the therapeutic will often
change over the course of the product's development. While there are many factors in play,
the ultimate goal is to have the filing of the device precede or be in concert with the filing
of the therapeutic. In order to effectively accomplish this task, the commercially ready test
should be employed in pivotal phase testing, and all interactions necessary for its implemen-
tation should be completed prior to pivotal phase start.
Search WWH ::
Custom Search