FDA releases new guidance for laser illuminated projectors.
The Food and Drug Administration (FDA) has announced a new “guidance document” concerning laser illuminated projectors (LIPs).
The FDA defines LIPs as “a type of demonstration laser product defined in 21 CFR 1040.10(b)(13) that is designed to project full-frame digital images.” The term “demonstration laser product” is defined under 21 CFR 1040.10(b)(13) as “any laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.”
Although laser light from LIPs is not as hazardous as other lasers, they are still laser products that present risks, and therefore must be classified in accordance to 21 CFR 1040.10(c), which “recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb).” Higher laser classes under this classification method correspond to more powerful lasers that have a higher potential to pose serious danger if used improperly.
The FDA’s emission limits and hazard classes are based on standards established by the International Electrotechnical Commission (IEC). LIPs and applications for these projectors “cannot exceed Class IIIa (which is comparable to IEC Class 3R) emission limits as specified in 21 CFR 1040.11(c) unless granted a variance by FDA under 21 CFR 1010.4.” For the purposes of this guidance document, the FDA has decided to rely on IEC’s classification standards when determining if a projector or application requires a variance, rather than classify LIPs according to both IEC and FDA standards. The FDA has made a form available to request a variance for projectors that exceed Class IIIa emission limits. To download this form, go to sndcom.us/207l9at.
It is important to note that, according to the FDA, guidance documents, including this guidance document concerning LIPs, “do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.”
According to the FDA, “this guidance only applies to LIPs with extended source emissions that meet all of the following criteria:
a) The projector is neither a children’s toy laser product nor a medical device.
b) The projector does not produce scanned laser radiation.
c) The projector’s laser illumination system is an alternative to a conventional projector light source.
d) The apparent light source subtends an angle greater than or equal to 0.005 radians (rad), when determined at a distance of 0.2 meter from the nearest point of human access (see Par. 6 of IEC 62471:2006). [According to Heidi Hoffman, Managing Director of LIPA (Laser Illuminated Projector Association), this measurement standard is somewhat controversial. The standard distance preferred by the international community is 1m, rather than the FDA’s preferred 0.2m.]
e) The emissions are only within the visible wavelength range of 400nm to 700nm.
f) The unweighted peak radiance levels do not exceed 1 MW * m-2 sr-1/α where α is the angular subtense of the source at 0.2m from the closest distance of human access and the radiance is averaged over a 0.0017 rad acceptance angle (see Par. 4.2.2 of IEC 62471:2006).
LIPs that do not meet all these factors are outside the scope of this guidance and FDA will continue to consider the requirements found at 21 CFR 1040.10(c) and 21 CFR 1040.11(c) for those LIPs.”
The FDA’s full LIP policy is outlined in section IV of this guidance document. To view the guidance document in its entirety, go to sndcom.us/207lp9A.
Editor’s Note: LIPA will offer more comprehensive details about this guidance document in a future issue.