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Regulatory Information
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Medical devices are regulated in the USA by the Food & Drug Administration (US-FDA),
and in Canada by Health Canada's Therapeutic Products Directorate (TPD).
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 the USA and Canada.
Note: The US-FDA uses roman numerals instead of numbers for these classes,
so in the USA, Solarc devices are "Class II".
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In USA
, Class II (Class 2) devices are 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 US-FDA/CDRH website at:
www.fda.gov/cdrh.
On the right side, go to Information Resouces>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:
510(k) Database Search
Device Listing Database Search
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
- 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.
Search using "Company Name" (Solarc), then press the blue "ID" number on the right.
Alternatively, go to
Health Canada's Medical Device home page.
Note:
On July-21-2008, Solarc's three Health Canada Medical Device Licences
(12783,62700,69833) were merged into one licence (12783).
The "First Issue Date" for all devices except the 1000 Series now appear as July-21-2008;
even though these devices were first licenced on June-16-2003 for 62700 (500 Series) and
Dec-02-2005 for 69833 (100 Series).
Also note that the 1000 Series was first licenced in Feb-1993 by
"Health and Welfare Canada" on Accession #157340,
prior to Canada's new Medical Device Regulations of May 1998.
Physician Prescriptions
Physician prescriptions are required for ALL shipments of UVB home phototherapy devices to private individuals at US addresses.
This is mandated by US Federal law according to the Code of Federal Regulations [21CFR801.109] "Prescription Devices".
This law also forces the labeling to state "Caution: Federal law restricts this device to sale by or on the order of a physician."
A prescription is required because:
- The physician's diagnosis is needed to assess if UVB phototherapy is the best treatment option;
- The physician is in the best position to judge if the patient is likely use the device responsibly;
- The physician plays a role in the ongoing safe use of the device,
including regular follow-up skin exams at least once per year,
as UV phototherapy is a known risk factor for skin cancer.
Note that in all cases, the prescription does NOT have to be written by a dermatologist;
any medical doctor (MD) is acceptable, including of course general practitioners (GPs).
Nurse practitioners are also acceptable.
Solarc Systems uses the words "physician" and "healthcare professional" interchangeably to define this group.
Your physician can write the prescription:
- using the "Physician's Approval" section in the Solarc Order Form;
- in a letter on the physician's letterhead;
- on a traditional prescription pad. (Then taped to the Order Form where indicated for faxing.)
Please keep a copy of your prescription for your records. Solarc does NOT require the original.
Procedure Codes - CPT/HCPCS
Healthcare Common Procedure Coding System (HCPCS)
Current Procedural Terminology (CPT)
In the United States, durable medical equipment (DME) is identified using the standardized "HCPCS level II coding system".
Level II codes consist of a single alphabetic letter followed by 4 numeric digits,
along with descriptive terminology that identifies a category of like items.
The coding system is maintained by the
US Department of Health & Human Sciences, Centers for Medicare & Medicaid Services (CMS).
The
CMS "Durable Medical Equipment" (DME) Center
has an
overview of the coding system.
For the Solarc/SolRx 1000 Series
6 foot panels the HCPCS code is
E0693
"UV light therapy system panel, includes bulbs/lamps, timer, and eye protection; 6 foot panel."
For the Solarc/SolRx 500 Series
and 100 Series, the HCPCS code is
E0691
"UV light therapy system panel, includes bulbs/lamps, timer, and eye protection;
treatment are 2 square feet or less."
"CPT" codes are used primarily to identify medical services and procedures furnished by physicians and other health care professionals,
and are therefore not applicable to Solarc home phototherapy device sales.
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Physician approval / prescription is required for all ultraviolet home phototherapy device and UV bulb orders.
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
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