What you need to know about UVB phototherapy regulations
Medical devices are regulated in Canada by Health Canada’s Therapeutic Products Directorate (TPD) and in the USA by the Food & Drug Administration (US-FDA). Medical devices are classified into one of Classes 1 to 4, where Class 1 represents the lowest risk, and Class 4 the highest risk. All Solarc/SolRx UVB phototherapy products are classified as “Class 2” in both Canada and the USA. Note: The US-FDA uses roman numerals instead of numbers for these classes, so in the USA, Solarc devices are “Class II”.
In Canada, Class 2 devices are subject to many controls, including: – Compliance to the Canadian Medical Device Regulations (CMDR) – Market authorization by means of initial and annual device licensing – Mandatory ISO-13488 or ISO-13485 Quality System and the associated annual 3rd party audits, and Mandatory Problem Reporting. The device licence listings for Solarc Systems can be found on Health Canada’s Medical Devices Licence Listing website at: www.mdall.ca. Click “Active Licence Search”, and use “Company Name” (Solarc). Alternatively, go to Health Canada’s Medical Device home page.
Note1: On July-21-2008, Solarc’s three Health Canada Medical Device Licenses (12783,62700,69833) were merged into one license (12783). The “First Issue Date” for all devices except the 1000‑Series now appear as July-21-2008; even though these devices were first licensed on June-16-2003 for 62700 (500‑Series) and Dec-02-2005 for 69833 (100‑Series). Also note that the 1000‑Series was first licensed in Feb-1993 by “Health and Welfare Canada” on Accession #157340, prior to Canada’s new Medical Device Regulations of May 1998.
Note2: All Solarc Systems’ UVB devices (UVB-Narrowband and UVB-Broadband) received Health Canada approval to add “Vitamin D Deficiency” to the “Indications of Use” (health conditions for which can be legally advertised) on the July 21, 2008 amendment of Solarc’s per Health Canada Device Licence #12783.
Note3: On January 05, 2011, Solarc received Health Canada approval to add our 4th device family, the E‑Series, to our existing Health Canada Device Licence #12783. Solarc’s Health Canada Medical Device Licence #12783 is shown at the bottom of this webpage.
In the USA, Class II (Class 2) devices are also subject to many controls, including:
– Compliance to the applicable sections of the Code of Federal Regulations (CFR)
– Market authorization by means of initial 510(k) application and ruling of substantial equivalence
– Submission of Initial & Product Change reports to the Center for Devices and Radiological Health (CDRH)
– Device Listing (One per product code)
– Mandatory “Good Manufacturing Practises” (GMP) Quality System
– Mandatory Problem Reporting
The US-FDA does not permit marketing use of 510(k) or other regulatory information. However, this information can be legally obtained from the US-FDA/CDRH website. On the right side, scroll down to Tools & Resources > Medical Device Databases, where you can search Premarket Notifications 510(k)’s and Device Listings. Search using “Applicant Name” (Solarc) or “Owner/Operator Name” (Solarc).
Use the following links to the FDA’s database searches:
Device Listing Database Search
Note1: (applicable to the USA only)
In 2011 and 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.
Physician prescriptions are optional for shipments to Canadian and International addresses, but mandatory for shipments to US addresses. For more information, please go to: Prescriptions.
For California Residents Only
This product can expose you to antimony oxide, which is known to the State of California to cause cancer, and toluene, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov