ROCKVILLE, Md.—Optical industry groups are voicing concerns over new guidelines for impact resistant lenses drafted by the Food and Drug Administration (FDA) which would require lenses to be drop-ball tested at the place of edging. The proposed guidelines, once finalized, could have far-reaching effects on operators of in-office labs as well as on consumers, VMail has learned through interviews with the FDA and other industry observers. It could create a financial and practical burden on eyecare professionals by requiring them to purchase lens testing equipment, as well as force ECPs to outsource lens-finishing processes to third-party laboratories. ECPs that conduct any type of edging would be viewed as the manufacturer and be subject to liability.

The FDA's Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance, issued the guidelines in late October, 2007 in the form of a draft guidance. The document provides the optical industry with questions and answers about the federal regulation for impact resistant lenses which has been in place since 1972, and updates the 1987 FDA draft guidance on impact resistant lenses.

The FDA has set Jan. 24 as the deadline for industry comments on the draft Q&A. A coalition of industry groups spearheaded by the Vision Council of America (VCA) is preparing to submit comments to the FDA.

“We’ve asked the FDA for an extension so we can have more time to comment,” said Ed Greene, CEO of the VCA . “We think the draft has incorrect information concerning the impact testing of edged lenses. It contains many contradictory statements and is very confusing. The Q&A implies there’s an issue with eye injuries and broken lenses, and that’s not accurate. It also implies that edged lenses have reduced strength, and we’re not sure that’s true.

“Another aspect of the proposed guidance is that lenses that are tested can’t be resold,” said Greene. “That will cost consumers millions of dollars and is totally unnecessary. We’re taking a strong stance on this issue and look forward to the opportunity of working with the FDA to help them come up with a better set of guidelines that will address these issues. We are also working closely with every other national organization.”

Bob Dziuban, executive director of the Optical Laboratories Association, said “OLA is working closely with VCA and other industry associations to produce a unified response. We will comment about the need for, and the and real-world feasibility of, the various changes that would result from implementation of this draft Q&A. OLA, and all industry organizations, share with the FDA the objective of producing eyewear of outstanding quality and safety. We are very glad to have the opportunity to discuss with the FDA the regulations that will control the production of that eyewear.”

John Stigi, director of the FDA's Division of Small Manufacturers, International and Consumer Assistance, which issued the draft Q&A, told VMail he welcomes input from the industry and will consider it carefully before finalizing the FDA’s recommendations.

“Nothing will be set in stone this month,” said Stigi. “The whole idea is to get feedback on the guidance. Our expectation is that another document will be issued, probably in the spring, that will include comments that have come in from the industry. If we see that there’s data that edging lens will not have significant impact on drop ball testing, we’ll clearly look at that.”

Stigi acknowledged that some of the language in the document is confusing and needs clarification.

“We really should have defined certain terms more clearly,” he said. “For example, there are no universal definitions of what some in the industry would call ‘semi-finished’ or ‘uncut.’ So we’re going to look into that.”

Stigi noted that until the Q&A is updated, the 1987 version still offers the government’s definitive interpretation of lens impact testing.

To read the full PDF version of the Impact-Resistant Lenses: Questions and Answers Draft Guidance go to the
New & Noteworthy section of the Vision Monday Web site.