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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 I to IV, where Class I represents the lowest risk, and Class IV the highest risk.
All Solarc/SolRx UVB phototherapy products are classified as "Class II" in both the USA and Canada.
In USA, Class II 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).
The following direct links to the database searches were functional when last checked:
510(k) Database Search
Device Listing Database Search
In Canada, Class II 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.
Physician Prescriptions
It is Solarc's long standing policy to collect a physician prescription for all home UVB phototherapy device sales worldwide.
In the USA, this is mandated by law because UVB phototherapy devices are subject to the Code of Federal Regulations [21CFR801.109] "Prescription Devices".
This forces the labeling to state "Caution: Federal law restricts this device to sale by or on the order of a physician."
In Canada, the Canadian Medical Device Regulations: Safety and Effectiveness Requirements
[PART 1, Section 10(c)] has a similar requirement to "reduce the risks to the extent possible",
and "provide protection appropriate to those risks".
The requirement for a physician prescription is reasonable, and in the best interest of the patient, 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.
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., 12 Parker Court, Barrie, ON, Canada L4N 2A6
Toll Free: 1.866.813.3357 Tel: 705.739.8279 Fax 705.739.9684
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