Dive Brief:

• FDA has finalized its guidance on the classification and regulatory requirements tied to certain laser products.

• The two documents describe regulators' approach to laser illuminated projectors (LIPs) and the performance standards of other devices featuring similar light-emitting technologies.

• FDA has made changes to both documents since the draft stage but the revisions fall short of full harmonization with International Electrotechnical Commission (IEC) standards.

Dive Insight:

FDA published draft guidance on the conformance of laser products to IEC standards at the start of last year and soon received pushback.

The Laser Illuminated Projector Association (LIPA) stated that FDA should have fully harmonized its standards with IEC, arguing that the proposed model "still requires extra validation and certification effort and associated costs" and accusing the agency of failing to show how the deviations from the international norms "contribute to an improved level of health and safety."

Danaher-owned Beckman Coulter was critical of parts of the draft, too, and pushed for a change it described as "crucial" for manufacturers of in vitro diagnostics. The change would have freed manufacturers from the need to comply with both sets of IEC standards referenced in the guidance.

Neither LIPA nor Beckman Coulter got exactly what they wanted in the final guidance. Against Beckman Coulter's wishes, the guidance still states lasers that are considered to be medical devices must conform with two sets of IEC standards.

Similarly, the final guidance falls short of the full harmonization with IEC that LIPA pushed for in its feedback. In finalizing the guidance, FDA rewrote large sections of the text to state the performance standards that are outside the scope of the document and clarify which IEC standards it thinks are not comparable with its own requirements.

Ultimately, FDA plans to harmonize its standards with those of IEC as it "acknowledges the advantages of one set of criteria and requirements worldwide," but has not yet done so.