Challenge

A medical device manufacturer preparing for a pivotal clinical study encountered a major regulatory hurdle when their extractables and leachables (E&L) testing returned many unidentified compounds. The lack of sufficient data posed a significant risk of FDA rejection, threatening to delay the entire pivotal study timeline and jeopardize the program’s future.

‍

Chemva’s Solution

Chemva swiftly conducted a comprehensive Material Risk Assessment (MRA), aligned with ISO 10993-18 and FDA expectations.

Our approach included integration of material composition data, manufacturing process inputs including sterilization and packaging, and device potential stability during use. By considering contact classification, we established there is a potential toxicological relevance for genotoxicity and carcinogenicity. The detailed MRA encompassed nearly 250 pages.

This structured MRA approach formed the basis for a scientifically sound justification that addressed regulator concerns without requiring repeat testing.

‍

Impact Delivered

Chemva’s rapid and methodical intervention resolved all FDA concerns regarding unknown extractables and enabled the partner to proceed with their pivotal clinical study on schedule. The E&L risk was successfully de-escalated, preserving both regulatory momentum and internal confidence in the device program.