By David Lennarz, Vice President and Co-Founder of Registrar Corp
Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products that were offered for sale prior to September 2, 2014 are required to submit premarket notification (510(k)) for those products to the U.S. Food and Drug Administration (FDA) by August 26, 2015 if they wish to continue selling them in the United States. Until June 2014, sunlamp products and UV lamps were considered class I medical devices and were exempt from 510(k) submissions. On June 6, 2014, FDA published a final order reclassifying them to class II devices subject to 510(k) submissions. FDA noted that there were approximately 25 firms registered as manufacturers of sunlamp products or UV lamps at the time of the final order publication.
For sunlamp products and UV lamps not offered for sale before September 2, 2014, the 510(k) submission requirement became effective on September 2. This is also true for devices offered for sale prior to September 2 that were required to submit a new 510(k) due to significant changes to the device. FDA’s decision to reclassify sunlamp products and UV lamps stemmed from new information evaluated by the agency which showed that UV radiation is a significant contributing factor in developing skin cancer, and the number of females exposed to indoor UV radiation who are diagnosed with skin cancer is increasing.
Multiple comments in the order expressed concern for 510(k) submissions in varying situations. FDA’s responses indicated that a sunlamp product and its UV lamp can be included in the same 510(k) submission whether the UV lamp is sold separately or not. UV lamp manufacturers do not need to submit a 510(k) for each possible tanning bed or booth for which the lamp may be used, but they must specify the type of sunlamp products with which the lamp is compatible. FDA allows bundled 510(k) submissions for related UV lamps.
Registrar Corp assists medical device companies with U.S. FDA regulation compliance and can review a 510(k). Registrar Corp’s Regulatory Specialists can verify that a 510(k) is properly formatted and contains all necessary elements and information. After reviewing a 510(k), Registrar Corp will submit the 510(k) to FDA, facilitate payment, and correspond with FDA on the company’s behalf. For assistance or questions about FDA regulations for medical device companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.