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The time-frame necessary to achieve these developmental milestones may
be long and uncertain, and we may not successfully complete these mile-
stones for any of our intended products in development.
Prior to conducting clinical trials, which are necessary to obtain approval
by FDA to market a product, we must obtain FDA clearance. Even after
obtaining clearance, the FDA can halt clinical trials at any time for safety rea-
sons or for any violations, by us or by the clinical investigators, of the FDA’s
requirements for conducting clinical trials. If we are unable to receive clear-
ance to conduct clinical trials, or if our clinical trials are halted by the FDA,
we would not be able to achieve any revenue from such products since it is
illegal to sell any medical device for human use without FDA approval.
Regulatory clearances or approvals, if granted, may include signicant limi-
tations on the indicated uses for which the product may be marketed. Prior
to granting such clearances or approvals, the FDA and certain foreign regu-
latory authorities often impose numerous requirements with which medical
device manufacturers must comply. FDA enforcement policy strictly prohibits
the marketing of cleared or approved medical devices for uncleared or unap-
proved uses. In addition, product clearances or approvals could be withdrawn
for failure to comply with regulatory standards or because of the occurrence
of unforeseen problems following the initial marketing. We will be required
to adhere to applicable FDA good manufacturing practice (“GMP”) regula-
tions and similar regulations in other countries, which include testing, control,
and documentation requirements. Ongoing compliance with GMP and other
applicable regulatory requirements will be monitored through periodic inspec-
tions by federal and state agencies, including FDA and CDHS, and by compa-
rable agencies in other countries. Failure to comply with applicable regulatory
requirements, including marketing products for unapproved uses, could result
in, among other things, warning letters, nes, injunctions, civil penalties, recall
or seizure of products, total or partial suspension of production, refusal of the
government to grant pre-market clearance or pre-market approval for devices,
withdrawal of clearances or approvals and criminal prosecution. Changes in
existing regulations or adoption of new governmental regulations or policies
could prevent or delay regulatory approval of our products.
There can be no assurance that we will be able to obtain FDA 510(k)
clearance or PMA approval for our products under development or other
necessary regulatory approvals or clearances on a timely basis or at all.
Delays in receipt of or failure to receive U.S. or foreign clearances or
approvals, the loss of previously obtained clearances or approvals, or