|
|
Vitamin D Phototherapy
Regulatory Info for Solarc UVB Equipment
|
In Canada,
all Solarc Systems' UVB devices (UVB-Narrowband and UVB-Broadband) received Health Canada approval
to add "Vitamin-D Deficiency" to the "Indications of Use" on July 21, 2008 per Health Canada Device Licence #12783.
This includes the E-Series, 1000-Series, 500-Series and 100-Series.
In the USA,
using the FDA's 510(k) process,
Solarc failed in its attempt to get "Vitamin-D Deficiency" added to the "Indications for Use",
because no comparable "predicate" (pre-existing) device existed,
and to obtain approval would instead have required a severely cost prohibitive Premarket Approval "PMA" application.
In the USA, Solarc is therefore NOT permitted to promote the devices for "Vitamin-D Deficiency";
and instead only for the approved "Indications for Use" of psoriasis, vitiligo and eczema.
In this context, "Vitamin-D Deficiency" is considered to be an "off-label" use,
but regardless a physician can still request information regarding the off-label use,
and the physician is legally permitted to write a prescription for the patient to obtain the product.
This concept is known as the "practice of medicine", which means that
a physician can prescribe or administer any legally marketed product for any off-label use
that they deem to be in the best interest of the patient.
For more detailed regulatory information, please visit the
regulatory webpage
on our primary website.
For detailed product and ordering information, please visit our primary website at
SolarcSystems.com
|
This website is not intended for use by residents of the USA.
Vitamin-D Deficiency is not an US-FDA approved Indication for Use.
Solarc Systems Inc., 1515 Snow Valley Road, Minesing (Barrie), Ontario, Canada L0L 1Y3
Toll Free: 1.866.813.3357 Tel: 705.739.8279 Fax 705.739.9684
|
|
|
|
