NCBFAA Clarifies FDA Import Requirements for Incandescent and Halogen Lamps
The Food and Drug Administration’s Center for Devices and Radiological Health still has some requirements for radiation-emitting halogen and incandescent lamps and bulbs, even though these products are not subject to an FDA performance standard, the National Customs Brokers &…
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Forwarders Association of America said in an emailed update sent April 23. Currently, only mercury vapor and metal halide lamps with an outer glass envelope are covered by a performance standard due to the risk of radiation if the glass envelope is broken, the NCBFAA said. But even though they are not covered, radiation-emitting halogen and incandescent lamps must still comply with FDA regulations on reporting accidental radiation, notification of defects and repurchases, repairs or replacement, the trade group said. However, “CDRH would be ok if these lamps are disclaimed during import entry since the technology surrounding these products is an old and proven technology,” the NCBFAA said.