Page 38 - enLIGHTenment - November 2017
P. 38
| legislationUpdatE
Why Is the FDA Concerned About LEDs?
Believe it or not, LEDs emit radiation – as do high-intensity mercury vapor discharge lamps –
and, as such, fall under the enforcement of the Food & Drug Administration.
A
ccording to ALA Engineering Commi ee member Carl
NEED MORE DEFINITION?
Bloom eld, Director/Lighting for the international inspection,
product testing and certi cation company Intertek, the FDA
Radiofrequency (RF) electromagnetic radiation
clari ed its enforcement of Light-Emi ing Diode (LED) reporting via
(EMR) is the transfer of energy by radio waves.
the U.S. Customs and Border Protection portal in June.
Any product that contains an electronic circuit and
He noted the FDA has regulatory authority over radiation-emi ing
generates any kind of radiation is an electronic product
electronic products, which are de ned in 21 CFR 1000.3 as any
electrically powered product that can emit any form of radiation on that emits radiation. X-radiation (X rays), microwaves,
radio waves, laser, visible light, sound, ultrasound, and
the electromagnetic spectrum (LED products emit visible optical
UV light are a few examples.
radiation).
Continued on page 38
WHICH PRODUCTS ARE REGULATED AS ELECTRONIC
PRODUCTS THAT EMIT RADIATION?
SOURCE: INTERTEK
Dealer &
Manufacturer
Distributor
Distribution
Product Supplemental Abbreviated Annual Test Distribution records
Report reports reports reports records records 1002.40 and
Product
1002.10
1002.11
1002.12
1002.13
1002.30(a)
1002.30(b)
1002.41
Phototherapy
Laser (1040.10, 1040.11)
Class I lasers and products containing such
lasers
Class I laser products containing class Iia,
II, IIIa, lasers
Class Iia, II, IIIa lasers and products other
than class I products containing such lasers
Class IIIb and IV lasers and products
containing such products
Sunlamp products (1040.20)
Lamps
Sunlamp products
Mercury vapor lamps (1040.30)
T lamps
R lamps
36 enLIGHTenment magazine | november 2017
WWW.enlightenmentmag.com
