GUIDANCE DOCUMENT
Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests October 2007
- Docket Number:
- FDA-2020-D-0957
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health
Background
A sunlamp product is an electronic product designed to use one or more ultraviolet lamp(s) and is intended for irradiation of any part of the living human body by ultraviolet radiation within a specified range of wavelengths to induce skin tanning. The ultraviolet lamps, subject to the performance standard, produce radiation within a prescribed range of wavelengths and are intended for use in sunlamp products.
Sunlamp products include portable home units, table top models, tanning beds and tanning booths. These units may incorporate different types of fluorescent lamps, reflector spot (RS) or High Intensity Discharge (HID) with different levels of energy output and radiation at different wavelengths.
Since sunlamp products are radiation-emitting electronic products as defined by Section 531 of Subchapter C- Electronic Product Radiation Control (EPRC) formerly the Radiation Control for Health and Safety Act (RCHSA) and medical devices as defined by Section 201(h)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA, the Act), they are regulated under both laws.
Under authority of Section 534 of the (EPRC), a performance standard for sunlamp products and ultraviolet lamps intended for use in these products was promulgated effective May 7, 1980 (21 CFR 1040.20). The standard was intended to reduce sunlamp related injuries by reducing unnecessary exposure and overexposure to sunlamp radiation by: (1) limiting shorter wavelength emissions that are not necessary and pose unreasonable risk, (2) providing for adequate warning label and user instructions containing safety information, and (3) requiring special lamp bases, protective eyewear, timers, and controls to help users limit the duration and amount of exposure.
This performance standard was promulgated when the common sunlamp product was a table-top, home portable unit incorporating one or two RS lamps having a large part of their radiation output in the wavelength range of 260 to 320 nanometers (UVB). In 1979-80, a new-wave of sunlamp products came onto the market. These products, commonly referred to as Tanning Booths, usually measured 3'x3'x7' and contained one or two fluorescent ultraviolet lamps in each corner. These products also had relatively high UVB output.
Around early 1983, another product in the shape of a bed and/or canopy entered the market with fluorescent lamps that emit radiation mainly in the 320-400 nanometer range (UVA), with usually less than 5% in-the UVB range. This type of product requires longer exposure times to achieve its intended purpose and the risk of chronic sunburn is reduced relative to the older type of products. Most manufacturers requested variance under 21 CFR 1010.4 to equip the products with timers which would allow exposure in excess of ten minutes. Since the products usually required 30 minutes to achieve their intended result, the variances were granted with two conditions: (1) the maximum timer interval shall not exceed the maximum recommended exposure time specified in the required product label, and (2) the UVB to UVA ratio shall not exceed .05 (no more than 5% UVB). The manufacturers are required to specify the variance number and effective date on the product).
Some of these products incorporate High Intensity Discharge (HID) lamps. These lamps are usually used for facial tanning, although some whole body exposure systems use such lamps exclusively. In most cases, however, these lamps are used in conjunction with ultraviolet fluorescent lamps. The HID lamps are much smaller than fluorescent lamps, (usually about 1/2" in diameter by 3" in length) and they usually incorporate an outer, clear, glass envelope.
On September 6, 1985, amendments to the performance standard were published and became effective in September 8, 1986. The purpose of the amendments is to accommodate new products employing design concepts significantly different from those for which the original standard was developed. Also, FDA experience in applying the original standard indicated that some requirements were either inappropriate for or not applicable to some products. The amendments are intended to establish a standard that is appropriate for the present technology of tanning and new sunlamp product designs. This revised program offers guidance for testing products against the original standard or revised standard, as appropriate.
Specific Instructions
Some electro-optics specialists, x-ray auditors and other radiological health specialists have been trained in general EPRC requirements and also may have specialized training in the sunlamp product performance standards. Only trained individuals should perform these inspections and field tests and may train additional field staff or accompany a medical device investigator to conduct joint EPRC/medical device inspections. If an EOS has training in both EPRC and QSIT inspections, a single EOS may conduct both portions of the inspection.
The District Offices have the authority (delegated under 21 CFR 5.37 and 5.89) to make declarations of noncompliance and/or defect for sunlamp products. The field also has the authority to approve sunlamp manufacturer corrective action plans under 21 CFR 1004 and to grant exemptions (from notification and product repair) in accordance with 21 CFR 1003.31. Consult CDRH for assistance in determining appropriate enforcement action or other support. A copy of any letter issued to a manufacturer must be sent to HFZ-240.
References
Sunlamp Products, Performance Standard – 21 CFR 1040.20.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.20
Quality Control Guide for Sunlamp Products. (Publication; FDA 84-8234)
Policy on Warning Label Required on Sunlamp Products (6/25/85)
Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products (8/21/86)
Policy on Lamp Compatibility (9/2/86).
Sunlamp Products Reporting Guide, (dated September, 1995).
Refer to the sunlamp products main page for additional information.
Sunlamp Product Codes
| Translation of 2-Digit Code | Product Name | Product Code | CFR | Definition | |
|---|---|---|---|---|---|
| Sunlamp Products (Certified) | Suntan Booth | 79 | LEJ | 1040.20 | |
| Sunlamp Products (Certified) | Suntan Bed, Sunlamp Products (Certified), Non-Medical | 95 | REF | 1040.20 | A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning with no medical claims. |
| Sunlamp Products (Certified) | Suntan Lamp, Sunlamp Products (Certified), Non-Medical | 95 | REG | 1040.20 | A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture with no medical claims. |
| Sunlamp Products (Certified) | Tabletop Sunlamp System (Certified), Non-Medical | 95 | REH | 1040.20 | A sunlamp system that sits on a table, primarily intended to tan the face by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers with no medical claims. |
| Sunlamp Products (Certified) | Other | 95 | RZZ | Unk | Sunlamp product means any electronic product designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. |
Classification of Non-compliant Items
| Performance Requirements | |||
|---|---|---|---|
| 1040.20(c)(1) | Fails to comply with the irradiance ratio limits for UVC over UVB cannot exceed 0.003 | Minor | Class B |
| 1040.20(c)(2)(i) | Fails to incorporate a timer system with multiple timer settings adequate for recommended exposure time intervals | Major | Class A |
| 1040.20(c)(2)(ii) | Maximum timer interval(s) is more than 3 times greater than the manufacturer’s recommended maximum exposure time(s) as indicated on label | Major | Class A |
| 1040.20(c)(2)(ii) | Maximum timer interval(s) is 2 – 3 times greater than the manufacturer’s recommended maximum exposure time(s) as indicated on label | Minor | Class B |
| 1040.20(c)(2)(ii) | Maximum timer interval(s) is less than 2 times greater than the manufacturer’s recommended maximum exposure time(s) as indicated on label | Concern | Class C |
| 1040.20(c)(2)(iii) | Maximum timer interval error > 30 percent | Major | Class A |
| 1040.20(c)(2)(iii) | Maximum timer interval error > 20 and < 30=""> | Minor | Class B |
| 1040.20(c)(2)(iii) | Maximum timer interval error > 10 and < 20=""> | Concern | Class C |
| 1040.20(c)(2)(iv) | Timer automatically resets and causes radiation to resume. | Major | Class A |
| 1040.20(c)(3) | Fails to incorporate a control for termination of radiation emission (at minimum a timer system) | Major | Class A |
| 1040.20(c)(4)(i) | Fails to have protective eyewear | Minor | Class B |
| 1040.20(c)(4)(ii) | Spectral transmittance of the protective eyewear exceeds a value of 0.001 over the wavelength UVC and UVB(200nm to 320nm) | Minor | Class B |
| 1040.20(c)(4)(ii) | Spectral transmittance of the protective eyewear exceeds a value of 0.01 over the wavelength UVA (>320nm to 400nm) | Minor | Class B |
| 1040.20(c)(4)(ii) | Spectral transmittance (>400nm) of protective eyewear does not allow user to clearly see to reset the timer | Minor | Class B |
| 1040.20(c)(5) | UV lamp capable of insertion and operation in either the “single-contact medium screw” or the “double-contact medium screw” lamp holders. | Major | Class A |
| Label Requirements for Sunlamp Products | |||
| 1040.20(d)(1)(i) | Fails to have warning statement “Danger UV radiation…” | Minor | Class B |
| 1040.20(d)(1)(ii) | Fails to have recommended exposure position(s) | Minor | Class B |
| 1040.20(d)(1)(iii) | Fails to have directions for recommended exposure position(s) and warning other positions may result in overexposure | Minor | Class B |
| 1040.20(d)(1)(iv) | Fails to have recommended exposure schedule | Minor | Class B |
| 1040.20(d)(1)(v) | Fails to have time before expected results statement | Concern | Class C |
| 1040.20(d)(1)(vi) | Fails to have ultraviolet lamp designation | Minor | Class B |
| Label Requirements for Ultraviolet Lamps | |||
| 1040.20(d)(2)(i) | Fails to have “Sunlamp-DANGER-Ultraviolet radiation. Follow Instructions” | Minor | Class B |
| 1040.20(d)(2)(ii) | Fails to have model identification | Minor | Class B |
| 1040.20(d)(2)(iii) | Fails to have “Use ONLY in fixture equipped with timer” | Minor | Class B |
| Label Specifications for Sunlamp Products and Ultraviolet Lamps | |||
| 1040.20(d)(3)(i) | Fails to be permanently affixed or inscribed on the exterior surface of sunlamp product when fully assembled for use so as to be legible and readily accessible to view by person being exposed immediately before use of product | Minor | Class B |
| 1040.20(d)(3)(ii) | Fails to be permanently affixed or inscribed on the ultraviolet lamp so as to be legible or readily accessible to view | Minor | Class B |
| 1040.20(d)(3)(iv) | Fails to have identification and certification labels on shelf package of ultraviolet lamps and coded mfr name and date of mfr on ultraviolet lamp | Minor | Class B |
| 1040.20(d)(3)(v) | Labels contain statements or illustrations that are false or misleading, diminish the impact of the required statements, or are prohibited by this chapter. | Major | Class A |
| Instructions to be provided to users of Sunlamp Products | |||
| 1040.20(e) | Inadequate instructions for use to avoid or minimize potential injury provided to purchaser | Minor | Class B |
| 1040.20(e)(1)(i) | Failed to have reproduction of “Danger Ultraviolet Radiation warning statement…” | Minor | Class B |
| 1040.20(e)(1)(ii) | Failed to have a statement of the maximum number of users and warning that only that number of protective eyewear was provided | Concern | Class C |
| 1040.20(e)(1)(iii) | Failed to have instructions on the proper operations of the product including function, use, and setting of the timer and other controls , and use of the protective eyewear | Minor | Class B |
| 1040.20(e)(1)(iv) | Failed to have instructions determining the correct exposure time and schedule for persons according to skin type. | Minor | Class B |
| 1040.20(e)(1)(v) | Failed to have instructions for obtaining repairs and recommended replacement components and accessories which are compatible with the product, including compatible protective eyewear, ultraviolet lamps, timers, reflectors, and filters, if installed or used as instructed would result in continued compliance with the standard. | Minor | Class B |
| 1040.20(e)(2)(i) | User instructions for ultraviolet lamps not sold with sunlamp products failed to have a reproduction of the “Danger Ultraviolet Radiations…warning statement and the “Sunlamp-DANGER Ultraviolet radiation. Follow Instructions” and “Use ONLY in a fixture equipped with a timer” label | Minor | Class B |
| 1040.20(e)(2)(ii) | User instructions for ultraviolet lamps not sold with sunlamp products failed to have a warning that instructions should be followed to avoid or minimize potential injury | Minor | Class B |
| 1040.20(e)(2)(iii) | User instructions for ultraviolet lamps not sold with sunlamp products failed to have a clear identification by brand and model designation of all lamps models for which replacement lamps are promoted | Minor | Class B |
| Tests for Determination of Compliance | |||
| 1040.20(f) | Fail to account for all errors and statistical uncertainties in the process for changes in radiation emission or degradation in radiation safety with age of the product. | Minor | Class B |
| 1040.20(f) | Fail to make measurements for certification under operational conditions as recommended by the manufacturer. | Minor | Class B |
| 1040.20(f) | Fail to position measuring instrument at recommended exposure position and oriented to result in maximum detection of the radiation | Minor | Class B |
Sample Sunlamp Product Inspection and Field Test Checklist
INSPECTIONAL FIELD TEST CHECKLIST REPORT FOR SUNLAMP PRODUCTS
MANUFACTURED AFTER SEPTEMBER 8, 1986
(Including Pertinent Parts of the Regulation)
FACILITY NAME:
PERSON INTERVIEWED:
ADDRESS:
TELEPHONE NUMBER
FIELD TEST DATE
WARNING LABEL [21 CFR 1040.20(d)(1)]
Accessible To View: Yes / No Legible From One Meter: Yes / No Exposure Position: Yes / No "DANGER" Statement:: Yes / No
If "NO" to any of the above, Explain:___________________________________________________________________________________
Exposure Schedule times: Minimum ____min. / Maximum ____min. Warning Label Location:_________________________________
List All Lamp Types Designated On Unit Labeling:_________________________________________________________________________
CERTIFICATION LABEL [21 CFR 1040.20(d) & 21 CFR 1010.2]
Adequate Certification: Yes / No Written In English: Yes / No Legible: Yes / No
If "NO" to any of the above, Explain:___________________________________________________________________________________
IDENTIFICATION LABEL [21 CFR 1040.20(d) & 21 CFR 1010.3] (AS APPEARS ON LABEL)
Name & Address of Manufacturer:______________________________________________________________
Model #:_______________________________ Serial #:_______________________ Date of Manufacture:___________________________
PROTECTIVE EYEWEAR [21 CFR 1040.20(C) (4)]
Maximum Number of Users for Sunlamp Product:__________
Number of pairs:___________ Model Type:_________________________ Manufacture:_______________________________________
Number of pairs:___________ Model Type:_________________________ Manufacture:_______________________________________
LAMPS IN UNIT [21 CFR 1040.20(d) (1) & (d) (2)] & LAMP COMPATIBLITY [21 CFR 1040.20 (e) 2 (iii)]
Total Number of Lamps in Unit:__________________ Lamp Compatibility Information : YES / NO / N/A
Lamp Model Designation:__________________________________ Number of Lamps: ______ Manufacture:__________________________
Lamp Model Designation:__________________________________ Number of Lamps: ______ Manufacture:__________________________
Facilities Lamp Supplier(s) (name, address, fax & phone #):_________________________________________________________________
TIMER [21 CFR 1040.20 (C)(2)]
Type of Timer: Digital / Electro-mechanical / Spring Wound / Token / Other:________________________________
Timer Capabilities:_________(Minimum Time) _________(Maximum Time) Timer Interval (i.e. 1min increments): ___________________
Timer Interval Compatible with Exposure Schedule: YES / NO, If "NO", Explain:_______________________________________________
Timer Manufacturer Name and Address:_________________________________________________________________________________
Timer Accuracy: 10%: __________min __________sec, 50%: ____________min __________sec, 100%:___________min ___________sec
(Note: Record Timer Accuracy in minutes and seconds for 10%, 50% and 100% of Maximum Timer Capability for the Sunlamp Product. Remote timers are acceptable provided all other requirements of (C)(2)/(3) are maintained.)
TERMINATION CONTROL [21 CFR 1040.20 (C)(3)]
Presence: YES / NO Description: Toggle / Push Pull / Push Button / Other:_________________________________
How is exposure re-initiated:________________________________________________________________________
USER INSTRUCTIONS [21 CFR 1040.20 (e) (1)] (i.e. owner manual / operator manual)
Provided by the Manufacturer: YES /NO, Available to Patrons: YES / NO, Contains Instructions To Determine Exposure Schedule and Skin Types: YES / NO, Contains Reproduction of "WARNING LABEL" : YES / NO, Contains Instructions for Obtaining Replacement
Parts and Repairs: YES / NO, If "NO" to any, Explain:___________________________________________________________________
_____________________________
INSPECTING DISTRICT
____________________________________
NAME OF PERSON AND TITLE
INSPECTIONAL CHECKLIST REPORT
FOR SUNLAMP PRODUCTS MANUFACTURED PRIOR TO SEPTEMBER 8, 1986
(Including Pertinent Parts of the Regulation)
Facility Name:
Person Interviewed:
Address:
Telephone:
Field Test Date:
Mfr. Name:
Mfr. Address:
Home District_________ CFN/FEI_________Product Type:________________________________________
Model_________Serial Number Date_________ Manufactured _________ / _________ / _________
Lamps: UV-A_____UV-B _____HID _____Properly labeled _____Mfr/Model:_______________________________________
Max Timer Setting _____Gradations_____Consistent w/exposure schedule:__________________________________
Timer Exceed Max. Recom. Exp._________Accuracy @ 10%___________ 50%___________ 100%___________
Type of Timer___________ (e.g. Token) Mfr. of Timer_______________How can user terminate exposure? ______________
How is exposure re-initiated? ____________________________________ Eyewear_________Sufficient #_________
Labeling visible w/eyewear ____ Eyewear Mfr. and Model_____________________________________________________
Certification Label: _______ (Va___________)Permanently affixed___________ Viewable_____________________
Location_____________________ Properly Worded____ Mfr. I.D. Label_______________________ Viewable_________
Full Name/Address_____________________ Date Mfrd.___________ Place Mfrd.________________
Warning Label: Readily Viewable_______ Location_____________________ Danger Statement ___________
Lamp Type___________ Min. exposure distance_______ How measured _____Warning: Min. exposure distance_________
Warning: Protective Eyewear _________ Warning: Max. exposure time_________ Exposure Schedule __________________
Time before results can be expected_______ Any misleading statements?__________________________________________
User's Instructions: Provided by the Mfr. ______ Available to patrons ____________________________________________
Contains copy of warning label_______ Instructions for replacement parts _______ Statement of # of people/eyewear _______
Equipment Recommendations: User position indicated _____ Timer error less than 10% ________ Temperature Control ________
Electrical Safety_________ Mechanical Safety_________ Protection from Lamps______ Access and Support ______
_____________________________
Name and Title
____________________________________
Inspecting District
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.