Latest News Opticians Mobilize to Fight FDA’s Proposed Drop Ball Guidelines By Staff Monday, January 7, 2008 12:52 AM RELATED CONTENT PBA Joins Groups Opposing FDA Lens Impact Regs PBA Becomes First Consumer Optical Group to Oppose FDA’s Changes to Lens Impact Test Guidelines Optical Coalition Responds to Proposed FDA Guidelines for Lens Impact Testing Industry Airs Views on FDA Lens Impact Guidelines VCA Reports Progress in FDA Drop Ball Talks OLA Presses FDA to Change Proposed Impact Testing Guidelines FDA to Extend Comment Period on New Lens Impact Guidelines Concern About Proposed FDA Guidelines for Lens Impact Tests HERNDON, Va.—Opticians across the country are joining the rising chorus of opposition to controversial new guidelines for impact resistant lenses drafted by the Food and Drug Administration (FDA) that would require lenses to be drop-ball tested at the place of edging. The guidelines, once finalized, could have far-reaching effects on operators of in-office labs as well as on consumers. Photo courtesy of Optical Machinery.The FDA has set Jan. 24 as the deadline for industry comments on the guidelines, which offer questions and answers about 1972 federal regulations on impact resistant lenses. The guidelines would update a 20-year-old document that is the FDA’s most recent interpretation of the regulations. A coalition of industry groups spearheaded by the Vision Council of America (VCA), including the Optical Laboratories Association and the Opticians Association of America, is preparing to submit comments to the FDA which challenge some aspects of the guidelines and seek to clarify points that appear to conflict with the regulation itself. The VCA has requested that the deadline be extended to allow for more time to submit comments. “OAA agrees there are several discrepanicies between the FDA Q&A document and the actual regulations,” said Catherine Langley, the group’s executive director. “It may just be a matter of pointing out irregularities to the FDA. I’m optimistimic they will change the Q&A.” OAA is encouraging members to protest the proposed guidelines by sending comments to FDA as well as to the OAA Legislative Action Center, a Web site the group operates. OAA president Tom Hicks of Oxford Opticians in Oxford, Ohio, added, “OAA's position is that we are not pleased with the Q&A that was just released and would like to see it revistited to better reflect the standards as they are written.” The proposed FDA guidelines 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. They would be required to keep detailed records of every lens edged in their office, an administrative task that would be difficult for independent opticians such as Hicks, the owner and sole employee of Oxford Opticians in Oxford, Ohio. “For most of our opticians that do their own finishing work, this would affect us greatly,” said Hicks. “I’m worried about how we would keep on top of the paperwork. We’d have to sign every [record], and keep it for three years. With the Q&A, as it stands now, the FDA could walk in any time and ask to see the records. That’s not acceptable.” Hicks said the FDA draft Q&A promises to be a hot topic at the upcoming OAA annual convention later this month in Charleston, S.C. Vision Monday wants to hear from you about this important issue. Go to visionmonday.com to voice your opinion in our new Reader Poll located toward the bottom of our Web site.