Biology Reference
In-Depth Information
Device/Test
Development
IDE review
Application
review
PMA or 510(k)
application
Investigational phase pre IDE or
IDE meeting as appropriate
Voluntary
submissions
VGDS
Prototype
design or
discovery
FDA filling/
approval &
launch
Clinical development
Basic
research
Preclinical
development
Phase 1
Phase 2
Phase 3
Pre-IND
meeting
End of phase
2A meeting
Drug market
application
Initial IND
submission
End of phase
2 meeting
Ongoing
submission
Pre-BLA or
NDA meeting
Application
review
IND review
Drug development
FIGURE 7.1 The graphic presented here from the Drug Diagnostic Co-Development Concept Paper depicts the
ideal timing of regulatory interactions and filings in concert with therapeutic filings.
7.3.5 Regulatory Pathways Outside of the United States
There are a number of regulatory considerations to consider when a companion diag-
nostic device is registered outside of the United States. As mentioned previously, it is cur-
rently believed that the US device approval is the most stringent of the regulatory paths
and even considered by some to be a hindrance to advancing the field [5,6] . However, other
regulatory bodies also have stringent approval processes in place. For example, the Japanese
Pharmaceutical and Medical Devices Agency (PMDA) have specific guidance indicating
the necessity for foreign manufacturers to have a marketing authorization holder in Japan
to sponsor the device and oversee the approval process [7] . These requirements must be
carefully considered and strategically planned for to ensure appropriate timing of medical
device filings in multiple geographic locations. In addition to the PMDA requirements, addi-
tional regulatory bodies have established guidelines and general provisions for the review
and approval of medical devices. An example of this is the 'Regulations for the Supervision
and Administration of Medical Devices', released by the Chinese State Food and Drug
Administration (SFDA) [8] . While it will not be covered in detail here, the document lays out
clear requirements and penalties for not fulfilling those device requirements. In contrast to
Japan and China, where there is clear oversight of device approval by a regulatory author-
ity, Europe utilizes a CE marking system which applies to all devices, not only medical
devices. The European Commission has issued a directive for the required documentation
required of the sponsor of in vitro diagnostic devices, yet specific regulatory approval has not
been required [9] . Instead the sponsor is required to prepare documentation stating that the
analytical and clinical performance of the device is reliable [9] . While this is only a cursory
 
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