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May 30, 2014
Regulatory Update – Reclassification Order for Sunlamps and Sunbeds
The outline below is a more detailed analysis of the reclassification order that will be published in the Federal Register on Monday June 2, 2014. That date is important because it starts the clock on the 90 day and 450 day compliance requirements in the order.
• FDA has reclassified sunlamp products (tanning beds and booths), and UV lamps intended for use in sunlamp products, from class I to class II medical devices.
• This reclassification means that sunlamp products and UV lamps intended for use in sunlamp products:
o Are subject to the 510(k) premarket notification requirements (subject to certain compliance dates described below):
• A 510(k) can be submitted for a sunlamp product plus UV lamp intended for use with that product;
• UV lamps will require a 510(k), but the manufacturer might be able to submit one “bundled” 510(k) for related lamps (in accordance with an FDA guidance document on bundling multiple devices in a single submission) and one 510(k) for a replacement lamp that can be used in multiple tanning beds/booths;
• The “predicate device” for sunlamp products and lamps can be a product that has a 510(k) clearance or “any 510(k)-exempt sunlamp product or UV lamp legally offered for sale on or before” the effective date of the order (which is 90 days from the date it is published in the Federal Register, expected to be Monday, June 2);
o Must conform to the established Special Controls for these devices, which include testing and labeling requirements;
o Testing requirements include the following, and the test data must be included in the 510(k)s:
• Performance testing on output performance specifications (such as wavelengths and energy intensity) and on proper functioning of safety features (such as timers to limit UV exposure times);
• Mechanical safety to prevent user injury;
• Software verification, validation, and hazard analysis (applicable to beds and booths, but not likely to UV lamps only);
• Biocompatibility (with respect to device parts that touch the human body);
• Electrical safety, and electromagnetic compatibility for the environment in which the product will be used;
o Labeling requirements include the following:
• Labeling requirements applicable to only sunlamp products:
• The black box warning “Attention: This sunlamp product should not be used on persons under the age of 18 years” must appear on all sunlamp products, consistent with the size and location requirements established by the order.
• Manufacturers must include validated instructions on cleaning and disinfecting sunlamp products between uses in their user instructions.
• Labeling requirements applicable to both sunlamp products and UV lamps intended for use in sunlamps:
• All user instructions, as well as consumer directed catalogs, specification sheets, descriptive brochures, and webpages in which these devices are offered for sale must contain these warning/contraindication statements:
• “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
• “Contraindication: This product must not be used if skin lesions or open wounds are present.”
• “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
• “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
• The effective date of the final order will be 90 days after publication of the order in the Federal Register.
• Compliance periods:
• Models of sunlamp products and UV lamps intended for use in sunlamp products (or significant changes or modifications to these models) that have not been offered for sale before the effective date of the final order, must obtain 510(k) clearance before the new or changed model may be marketed.
• For models of sunlamp products and UV lamps intended for use in sunlamp products that are offered for sale before the effective date of the final order and continue to be offered for sale after the effective date of the final order, a manufacturer must submit a 510(k) and comply with the labeling special controls by 450 days after publication of the final order in the federal register.
• If a manufacturer does not submit the required 510(k) within the 450 days following publication of the order, or the labeling special controls for a device are not followed within 450 days following publication of the order, or FDA does not clear a filed 510(k) premarket notification (i.e., the agency issues a not substantially equivalent (NSE) order), then the device at issue is considered adulterated and misbranded and can no longer be lawfully held for sale.
• If a sunlamp product or UV lamp has been shipped to operators/users/individual consumers before the effective date of the final order and the model has been discontinued or is otherwise no longer offered for sale, the device must still comply with the labeling special controls within 450 days of the effective date of the final order.
• If the manufacturer of the device is no longer in business, then it is the responsibility of the sunlamp product owner to apply the required labeling.
From the ITA
May 30, 2014
Regulatory Update – Reclassification Order for Sunlamps and Sunbeds
The outline below is a more detailed analysis of the reclassification order that will be published in the Federal Register on Monday June 2, 2014. That date is important because it starts the clock on the 90 day and 450 day compliance requirements in the order.
• FDA has reclassified sunlamp products (tanning beds and booths), and UV lamps intended for use in sunlamp products, from class I to class II medical devices.
• This reclassification means that sunlamp products and UV lamps intended for use in sunlamp products:
o Are subject to the 510(k) premarket notification requirements (subject to certain compliance dates described below):
• A 510(k) can be submitted for a sunlamp product plus UV lamp intended for use with that product;
• UV lamps will require a 510(k), but the manufacturer might be able to submit one “bundled” 510(k) for related lamps (in accordance with an FDA guidance document on bundling multiple devices in a single submission) and one 510(k) for a replacement lamp that can be used in multiple tanning beds/booths;
• The “predicate device” for sunlamp products and lamps can be a product that has a 510(k) clearance or “any 510(k)-exempt sunlamp product or UV lamp legally offered for sale on or before” the effective date of the order (which is 90 days from the date it is published in the Federal Register, expected to be Monday, June 2);
o Must conform to the established Special Controls for these devices, which include testing and labeling requirements;
o Testing requirements include the following, and the test data must be included in the 510(k)s:
• Performance testing on output performance specifications (such as wavelengths and energy intensity) and on proper functioning of safety features (such as timers to limit UV exposure times);
• Mechanical safety to prevent user injury;
• Software verification, validation, and hazard analysis (applicable to beds and booths, but not likely to UV lamps only);
• Biocompatibility (with respect to device parts that touch the human body);
• Electrical safety, and electromagnetic compatibility for the environment in which the product will be used;
o Labeling requirements include the following:
• Labeling requirements applicable to only sunlamp products:
• The black box warning “Attention: This sunlamp product should not be used on persons under the age of 18 years” must appear on all sunlamp products, consistent with the size and location requirements established by the order.
• Manufacturers must include validated instructions on cleaning and disinfecting sunlamp products between uses in their user instructions.
• Labeling requirements applicable to both sunlamp products and UV lamps intended for use in sunlamps:
• All user instructions, as well as consumer directed catalogs, specification sheets, descriptive brochures, and webpages in which these devices are offered for sale must contain these warning/contraindication statements:
• “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
• “Contraindication: This product must not be used if skin lesions or open wounds are present.”
• “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
• “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
• The effective date of the final order will be 90 days after publication of the order in the Federal Register.
• Compliance periods:
• Models of sunlamp products and UV lamps intended for use in sunlamp products (or significant changes or modifications to these models) that have not been offered for sale before the effective date of the final order, must obtain 510(k) clearance before the new or changed model may be marketed.
• For models of sunlamp products and UV lamps intended for use in sunlamp products that are offered for sale before the effective date of the final order and continue to be offered for sale after the effective date of the final order, a manufacturer must submit a 510(k) and comply with the labeling special controls by 450 days after publication of the final order in the federal register.
• If a manufacturer does not submit the required 510(k) within the 450 days following publication of the order, or the labeling special controls for a device are not followed within 450 days following publication of the order, or FDA does not clear a filed 510(k) premarket notification (i.e., the agency issues a not substantially equivalent (NSE) order), then the device at issue is considered adulterated and misbranded and can no longer be lawfully held for sale.
• If a sunlamp product or UV lamp has been shipped to operators/users/individual consumers before the effective date of the final order and the model has been discontinued or is otherwise no longer offered for sale, the device must still comply with the labeling special controls within 450 days of the effective date of the final order.
• If the manufacturer of the device is no longer in business, then it is the responsibility of the sunlamp product owner to apply the required labeling.
From the ITA