New Guidelines drafted by the Food and Drug Administration (FDA) will require that in 2008 all lenses be drop-ball tested at the place of edging and cutting due to concerns that the lens finishing process affects the integrity of the lens and the safety of the patient.

Not only could this recommendation create a financial and practical burden on ECPs by forcing them to purchase lens testing machinery, it could also force ECPs to completely outsource the testing and lens-finishing processes to third-party laboratories. ECPs that conduct any type of edging would be viewed as the manufacturer and subject unnecessarily high levels of liability. 

	Fact Sheet		What the new Q&A means
	VCA Position		FDA Draft Guidance Document

By taking action, you can help prevent these guidelines from affecting your practice. Let the FDA know:

• The safety record for eyeglass lenses is excellent. The frequency of eye injury litigation involving fractured lenses is approximately one claim per year, a very low number considering that over 146 million Americans regularly wear eyeglasses.
• Manufacturers have decades of experience ensuring lens safety by utilizing the drop ball test accurately.
• No major ophthalmic or consumer rights organizations are seeking changes to the guidelines released in 1987.

 
You can submit comments electronically to the FDA by clicking here, or mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The deadline for comments is January, 24, 2008, so act today!

For technical questions, please contact Ken Wood at  ken@woodcolorado.com or Jeff Endres at jeffendres@cox.net. For policy/regulatory questions, please contact Eve Zartman-Ball at ezb@visionsite.org