The Laser Institute Highlights Importance of Laser Safety Following FDA Import Alert

By Coyri Terry

Orlando, FL – May 29, 2024 – The Laser Institute of America (LIA), the authoritative voice in laser safety and applications, announces a critical update from the Federal Food and Drug Administration (FDA) regarding Import Alert 95-05. This alert, titled “Detention Without Physical Examination of Electronic Products that Fail to Comply with Performance Standards or to Have Required Certification,” underscores the necessity of adhering to stringent safety standards for laser equipment imported into the United States.
The FDA’s recent alert emphasizes the importance of safe design and operation of laser products to protect US workers. This alert aims to prevent non-compliant laser equipment from entering the US market, ensuring that all laser products meet the required performance standards and certification criteria.

Key Points from FDA Import Alert 95-05:

  • Compliance Requirements: Laser equipment must comply with applicable performance standards prescribed by the FDA and have proper certification as specified in 21 CFR 1010.2 and section 534(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Detention Without Physical Examination (DWPE): Non-compliant laser products may be detained at US ports of entry without physical examination, pending further investigation and corrective actions.
  • Conditions for Detention: Products may be detained for lack of a permanently affixed label, deficient test and quality control evidence, or invalid certification reports.

“Ensuring the safety of personnel that work with and around lasers is a top priority for LIA,” said Shaun Oleson, General Manager of LIA. “The FDA’s Import Alert 95-05 serves as a crucial reminder of the importance of compliance with laser safety standards. We urge all manufacturers, importers, and users of laser equipment to adhere to these standards to protect workers and maintain the integrity of the laser industry.”

LIA highlights the following steps for industry professionals to ensure compliance:

  • Review FDA Requirements: Familiarize yourself with the FDA’s performance standards and certification requirements for laser equipment.
  • Ensure Proper Certification: Verify that all laser products have the required certification labels and documentation.
  • Implement Quality Control: Maintain robust quality control and testing programs to meet FDA standards.

The Laser Institute encourages its members and the broader laser industry to review FDA Import Alert 95-05 and take necessary actions to comply with the outlined safety standards. For more information on the alert and to access resources on laser safety, visit the FDA’s official website at https://www.accessdata.fda.gov/cms_ia/importalert_255.html.

About LIA:
The Laser Institute of America (LIA) is a leading organization dedicated to fostering lasers, laser applications, and laser safety worldwide. As the ANSI-accredited Standards Developer of the Z136 American National Standards for the Safe Use of Lasers, LIA sets the benchmark for laser safety standards and offers comprehensive training and resources for laser safety officers and industry professionals. LIA’s mission is to cultivate innovation, ingenuity, and inspiration to promote the continued growth and safe use of laser applications.

For further information, please contact:
Jana Langhans
Marketing Manager, LIA
Email: press@lia.org