02 Oct 2017

Shining a Light on FDA LED Requirements

The International Trade Commission (ITC) has recently issued guidance to address confusion regarding entry reporting requirements for LED lights and products containing LEDs. LED products are radiation emitting devices that emit visible radiation and fall under the jurisdiction of the Food & Drug Administration (FDA) per the 21 CFR 1000.3 (a) Accidental Radiation Occurrence reporting requirement and regulations.

Current FDA guidelines regarding LED lights and illuminating products cover:

Types of LED Lights under FDA

  • General and local illumination
    • i.e., lamps, light bulbs

Requirements of FDA

  • Set at FD2; Subheading HTSUS 8541.40.2000

Expectations of FDA

  • Accurate and consistent entry of LED products
    • Though there are no performance standards, manufacturers are still subject to general requirements
  • Transmission of entry documentation
    • Does not expect for finished products that use LED lights as indicator lights
      • toys, cell phones, tablets.
    • Does not expect annual reports on these products
  • However, several companies have filed complaints regarding filing requirements for LED lights and products that are not for medical use. The ITC has opened the floor for interested parties to file comments and concerns regarding the importation of these products.

ITC is mainly interested in comments that:

  • State how articles subject to recommended remedial orders are used in the U.S.
  • Identify public health, safety, or welfare concerns
  • Identify similar or competitive articles that complainants make in the U.S. which could replace the item of interest if it were to be excluded
  • Indicate whether complainant has the means to replace volume of articles potentially subject to requested exclusion order within a reasonable timeframe
  • Explain how requested remedial orders would impact U.S. consumers

Written submissions of this nature must be filed by OCTOBER 9TH, 2017 by close of business.

To view the full guidelines for complaint or comment submission, visit Federal Register: Notice of Receipt of Complaint Solicitation Related to Public Interest.