RELATED CONTENT

FAIRFAX, Va.—Responding to a call by the Food and Drug Administration (FDA) for comments on its Draft Q&A Guidance on Lens Impact Testing, the Optical Laboratories Association (OLA) has stepped forward with a series of recommended changes that reflect the concerns of optical laboratory operators.

“OLA members have a major portion of the responsibility for compliance with impact testing requirements, and are very heavily invested in impact testing of spectacle lenses. We are very glad to have the opportunity to participate in the dialogue with the FDA about changes in the implementation of the impact testing regulations,” said Bob Dziuban, OLA executive director. “Our comments focused on two specific areas where we believe the FDA should review and change the guidance published in the Draft Q&A document. OLA joins with all the organizations in the optical industry in requesting that the FDA give careful consideration to the need for the changes in the Draft Q&A Guidance, and the economic impact those changes will have on consumers.”

 
Photo courtesy of Optical Machinery.
OLA is contesting several key provisions in the Draft Q&A. The association recommends that the FDA remove Question 5 from the Draft Q&A, or revise the guidance to reflect data indicating that lenses that pass impact testing once remain safe for use. OLA said it has collected data on 2,550 lenses that passed impact testing in accordance with 21 CFR § 410. In all but 0.27 percent of instances, those lenses passed impact testing a second time. OLA believes that this data indicates that lenses that have passed impact testing remain safe under the standards of 21 CFR § 410. According to OLA, Question 5 would have an adverse financial impact on consumers, with no additional safety benefit.

OLA also recommends that the FDA revise its provisions regarding third-party testing and certification of impact resistance found at Questions 25 and 26 of the Draft Q&A. OLA believes that the current third-party certification process contemplated by Question 26 is inconsistent with the principle, reflected throughout the Draft Q&A, that lenses should be tested by the “manufacturer” in their finished form. The association pointed out that when a third-party conducts impact testing on a lens that it has rendered in finished form through edging or surfacing, the results of that testing will not accurately reflect the impact resistance of the same lens when it is rendered in finished form by the “manufacturer.”

OLA believes that optical laboratories that participate in third-party testing and certification of impact resistance will be required to assume considerable increases in liability insurance premiums, resulting in higher prices to consumers. Therefore, the association is urging the FDA to require that third-party testing be conducted on lenses that have been rendered in finished form by the “manufacturer.”

Finally, OLA recommends that the FDA revise certain terminology and definitions used in the Draft Q&A to more accurately reflect the language used in the optical industry.

FDA officials said they will continue to accept comments on the Draft Q&A beyond the original 90-day deadline, which expired on Jan. 24.

View a PDF of the FDA’s Draft Guidance on Impact-Resistant Lenses to the Division of Dockets Management.

View a PDF of Optical Laboratories Association's Comments Regarding FDA's Impact-Resistant Lenses Questions and Answers Guidance.

Vision Monday encourages readers to send their comments about the FDA’s Draft Guidance on Impact-Resistant Lenses to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. All comments should be identified with docket number fr26oc07-76.