| As a manufacturer of medical
devices, NovaRay is subject to the regulations
and oversight of the United
States Food and Drug Administration (FDA).
X-ray based cardiac catheterization systems are
classified by the FDA as Class II devices, and
are subject to performance standards outlined
in the Code of Federal Regulations.
510(k) Premarket Notification
NovaRay submitted a 510(k)
premarket notification to the FDA seeking
clearance “…for use in generating
real-time fluoroscopic images in patients where
medically indicated.”
Quality System Regulation
NovaRay intends to be in strict compliance with
Federal regulations, referred to as the Quality
System Regulation (QSR), which includes the
Good Manufacturing Practices (GMP) that define
the elements of quality assurance. These practices
will be established prior to system design validation,
production, and distribution, and are subject
to periodic audits by the FDA.
International Regulation
International sales of medical devices are subject
to foreign government regulations, which vary
substantially from country to country. The time
required to obtain approval by a foreign country
may be longer or shorter than that required for
FDA approval, and the requirements may differ.
The primary regulatory environment in Europe
is that of the European Union, which consists
of 15 countries encompassing most of the major
countries in Europe. Other countries, such as
Switzerland, have voluntarily adopted laws and
regulations that mirror those of the European
Union with respect to medical devices. The European
Union has adopted numerous
directives and standards regulating the design,
manufacture, clinical trials, labeling, and adverse
event reporting for medical devices. Devices that
comply with the requirements of a relevant directive
are entitled to bear CE (European Compliance)
conformity marking, indicating that the device
conforms with the essential requirements of the
applicable directives and, accordingly, can be
commercially distributed throughout the European
Union. NovaRay has not yet applied for approval
in Europe.
In Japan, the Ministry of Health, Labor and Welfare
must approve our device. NovaRay has not yet applied
for approval in Japan.
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