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FDA lens testing rules could have far-reaching effects
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New guidelines written by the Food and Drug Administration for testing spectacle lenses could have a devastating impact on the optical industry if they are adopted, according to two industry leaders.
 Ed Greene |
“I don’t know that optometrists really understand how much this could affect them,” Ed Greene, chief executive officer of Vision Council of America (VCA), told Primary Care Optometry News. “This could cost their practice a lot of money. It’s a major impact.”
The draft guidance, issued by the FDA’s Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance in October 2007 in question-and-answer form, would require that all lenses be drop-ball tested where they are edged.
About 48% of independent optometric practices own some type of edging equipment, according to pre-show surveys taken at International Vision Expo East and West. Another 14% reported owning both edging and surfacing equipment. U.S. regulations require that all spectacle lenses be impact resistant – capable of withstanding impact from a 5/8-inch diameter steel ball dropped from 50 inches.
Historically, plastic lenses have been sample tested at the labs before edging takes place. Shifting the testing to where the lenses are edged would mean eye care professionals who do in-office edging would have to buy lens-testing equipment, as well as assume liability because they will be viewed as manufacturers, Mr. Greene said.
 Bob Dziuban |
“One of the other things that this current draft says is that a plastic lens that has been drop-ball tested cannot then be sold,” Bob Dziuban, executive director of the Optical Laboratories Association told PCON in an interview.
“Smaller offices that do a limited amount of edging would have to make a lens for every lens they sold. No one could stay in business doing that,” he said.
“There’s currently an argument that the industry is going to present to the FDA that says doing the drop-ball test on the lens does not in and of itself make the lens unsafe to dispense,” he continued. “OLA will supply data indicating that there is no reason for there to be a statement that you can’t sell a tested lens.”
Questions and answers
Industry groups, led by the VCA, are preparing their industry comments to the FDA for this draft guideline, called a Q&A.
“This is the government’s way of engaging interested parties in a dialogue,” Mr. Dziuban said. “The regulations were written back in the 1970s. In 1987, there was a new Q&A document.
“Currently the 1987 guidance document and the law not only conflict but also are not particularly clear when the impact testing must be done on a plastic lens,” he continued. “They leave it very open and ambiguous on whether it must be done an on uncut or on an edged lens. This 2007 Q&A comes right out and says it should be done on the edged lens.”
John Stigi, director of the FDA’s Division of Small Manufacturers, International and Consumer Assistance, which issued the proposed guidelines Q&A, told PCON that “the ‘new’ document is essentially the same as the 1987 guidance.
“We realize that technology has changed and business practices have changed and so we issued the draft document to solicit comments from the industry,” Mr. Stigi said. “We encouraged stakeholders to submit comments within 90 days of publication.”
The FDA requested comments prior to Jan. 24, 2008. However, Mr. Stigi said, “comments may still be submitted after that date. “In addition, I requested that the draft guidance be ‘re-announced’ so interested parties are aware they have additional time to comment.”
Testing after edging
Mr. Greene said testing after edging is unnecessary. “There’s no real need,” he said. “We don’t know any major issues of eye damage from broken lenses.”
In fact, according to a VCA fact sheet, about one eye injury litigation claim is filed per year. More than 146 million American adults wear spectacles on a regular basis, the document said.
Financial burden
The move would create a tremendous financial burden on optometrists, who would then pass the mounting costs onto consumers, Mr. Greene said.
“If an optician or optometrist that actually edges lenses has to test lenses and throw them away, there will be a tremendous consumer cost as well,” he said. “If a retailer has to become a manufacturer, they would have to meet all the manufacturer’s requirements. Government reporting and other things go with it. The major issue is that the cost of actual testing is really big.”
For more information:
- Ed Greene, chief executive officer of Vision Council of America, can be reached at 1700 Diagonal Road, Suite 500, Alexandria, VA 22314; (703) 548-4560; fax: (703) 548-4580; e-mail: egreene@visionsite.org.
- Bob Dziuban, executive director of the Optical Laboratories Association, can be reached at 11096 Lee Highway, Suite A-101, Fairfax, VA 22030-5039; (703) 359-2830; fax: (703) 359-2834; e-mail rdziuban@ola-labs.org.
- John Stigi, director of the FDA’s Division of Small Manufacturers, International and Consumer Assistance, can be reached at 5600 Fishers Lane, Rockville, MD 20857; (888) 463-6332; e-mail john.stigi@fda.hhs.gov.
- The Draft Guidance for Industry and FDA Staff, Impact-Resistant Lenses: Questions and Answers, is available for viewing online at www.fda.gov/cdrh/dsmica/guidance/23.pdf. Comments can be submitted by mail to Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852; by fax to (301) 827-6870 or by calling the FDA’s public room for assistance at (301) 827-6860.