editor's letter

Don't drop the…

by Stephanie K. De Long

Ball, and let the FDA pass guidelines for lens impact resistance that can negatively impact your business.

Among other things, the FDA's draft of new guidelines involving Drop Ball Testing requirements proposes that the testing be done after edging—which means those of you who edge lenses will be responsible for drop ball testing using statistical sampling methods. Afterwards, all tested lenses would need to be discarded.

Fortunately, the FDA—which may already be modifying its position thanks to input from organizations like the Vision Council—asked for public comment before putting new guidance into effect.

That period has been extended but ends April 24, so now is the time to make your voice heard. Here are just a few of the reasons why, even if you don't edge yourself, this is an issue that can't be ignored.

• COSTS. The Vision Council estimates this could cost the industry more than $50 million a year, resulting in increased costs to you and your patients.

• LIABILITY. You would be liable for injuries to consumers wearing lenses you edged.

• OPTIONS. The rules would discourage in-house edging, an option that currently saves many businesses both time and money.

• TURNAROUND. More edging would be done by labs. Though electronic files can alleviate many potential problems, labs would sometimes have to either edge without the frame in hand or wait until it arrives. Short term, this could affect turnaround.

• DISTRIBUTION. Looking longer term, the Vision Council suggests that these rules could change the balance of distribution, with labs again stocking frames the way they used to.

You only have a short time left to voice concerns. So, take a few minutes and write to: Food and Drug Administration, Division of Dockets Management (HFA-305), Re. Docket No. 2007D-0364, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Stephanie K. De Long
Editor-in-Chief

P.S. Please feel free stop by and say hello to us at Vision Expo East (booth number 1474).