Ensure Ophthalmic Device Quality Through Testing & Characterization

Katie Grayson, General Manager of Medical Device Services, leads this insightful webinar focused on device quality, specifically chemical characterization and analytical challenges in ophthalmic medical devices. She is joined by Rick Kemp, President of Biopharma Product Testing, who brings over 30 years of experience in analytical chemistry and laboratory operations. This session is the first of a two-part series, with the second scheduled for September 2025 to address ophthalmic combination and drug products.

The presentation provides a foundational understanding of ophthalmic device classifications and the associated regulatory landscape. Devices are categorized based on risk: Class I (low risk, e.g., eye cups), Class II (moderate risk, e.g., contact lenses), and Class III (high risk, e.g., implantable lenses). Approval pathways include the 510(k) process for Class II devices and premarket approval (PMA) for Class III, along with de novo classification and Humanitarian Device Exemptions for rare conditions.

The session emphasizes the importance of aligning testing strategies with device classification to ensure regulatory compliance and mitigate risks. Case studies and common analytical methods are presented to illustrate best practices.

The webinar also situates ophthalmic devices within a broader public health context. Vision impairment affects over 2.2 billion people worldwide, with preventable or unaddressed conditions contributing significantly to productivity losses exceeding $400 billion. Common causes include refractive errors and cataracts, primarily affecting individuals over 50.

Finally, the session highlights Quality Systems Regulation under 21 CFR Part 820, detailing essential requirements for device manufacturing, from design controls to corrective actions and record-keeping.