The folks at the FDA must have leaped before they looked when drafting new guidelines for lens impact resistance regulations. Rather than shed light on the regulation, which has been on the books since 1972, the proposed guidelines, issued in October 2007, are confusing and contradictory. If finalized, though, they could have far-reaching effects on operators of in-office labs as well as on consumers. For example, the guidelines could create a financial and practical burden on ECPs by requiring lenses to be drop-ball tested at the place of edging. ECPs would have to purchase lens testing equipment and 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.
When I asked an FDA official what prompted the agency to issue the draft guidelines, he said people were seeking clarification of the 36-year-old regulation as well as the previous draft guidance, which was issued in 1987. That’s reasonable. However, the FDA should have checked with industry sources before issuing the draft. It could have avoided confusion over the use of basic terms such as “semi-finished” and “uncut” as well as learned about the effectiveness of current drop ball testing methods, which many believe are adequate.
Responding to industry requests the FDA is extending the deadline for public comment until late April. That’s encouraging and indicates the FDA is willing to get as much feedback as possible before taking any action.
I invite readers to submit comments to the FDA’s Division of Dockets Management (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Refer to docket number fr26oc07-76.