Condom testing guidance

Executive Summary

Regulatory guidance, sampling plans for air burst testing included in 1draft revised compliance policy guide on male condom defects, FDA says in Federal Register March 29. Agency is implementing air burst testing "as a measure of elasticity and strength" due to concerns about latex condoms' ability to resist breakage, FDA says. Draft revised CPG also lowers acceptable quality level for water test leakage from .4% to .25% to conform with referenced standards. CPG includes a "lot" definition for FDA sampling, provides more specific guidelines on sampling, analyses...